Pharmacokinetics and safety of subcutaneous pasireotide and intramuscular pasireotide long-acting release in Chinese male healthy volunteers: a phase I, single-center, open-label, randomized study.

Chen X, Shen G, Jiang J, Liu H, Hu K, Darstein C, Lasher J, Hu P

Clinical therapeutics8 Jul 2014Cited by 12 (Europe PMC)

PMID25012727DOI10.1016/j.clinthera.2014.06.006PepBankPUB-25012727

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study19

19 results from studies that gave the peptide. 19 results from people.

01HumanNon-randomized trialSafety outcome
In Chinese healthy men receiving pasireotide formulations, 2 discontinued the study because of adverse events.
In plain wordsIn Chinese healthy men receiving pasireotide formulations, 2 stopped the study because of adverse events.
Peptide
Pasireotide
Outcome
Not applicableDiscontinuation due to adverse events
Study
n = 45
Outcome group
Adverse events · Whole body
Studied dose
single SC dose of 300, 600, or 900 μg on day 1, then the same dose BID; single IM dose of 20, 40, or 60 mg pasireotide LAR on day 33 · subcutaneous and intramuscularAs given in this study (human).
Measurements
Volunteers who prematurely discontinued because of adverse events
2 volunteers
of 45 randomized Chinese male healthy volunteers
Source sentences
Summary
Of the 45 randomized HVs, 42 completed the study per protocol, 1 withdrew his informed consent for personal reasons, and 2 prematurely discontinued the study because of adverse events (AEs).
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272701
02HumanNon-randomized trialSafety outcome
In Chinese healthy men receiving pasireotide formulations, no serious adverse events were reported.
In plain wordsIn Chinese healthy men receiving pasireotide formulations, no serious adverse events were reported.
Peptide
Pasireotide
Outcome
Not applicableSerious adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
single SC dose of 300, 600, or 900 μg on day 1, then the same dose BID; single IM dose of 20, 40, or 60 mg pasireotide LAR on day 33 · subcutaneous and intramuscularAs given in this study (human).
Source sentences
Summary
No serious AEs were reported.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272709
03HumanNon-randomized trialSafety outcome
In Chinese healthy men, subcutaneous pasireotide caused transient changes in glucose metabolism.
In plain wordsIn Chinese healthy men, subcutaneous pasireotide temporarily changed glucose metabolism.
Peptide
Pasireotide
Outcome
Direction not reportedTransient glucose metabolism changes with SC formulation
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
single SC dose of 300, 600, or 900 μg on day 1, then the same dose BID · subcutaneous · single dose on day 1, then BID from day 15 to the morning of day 19As given in this study (human).
Source sentences
Summary
Both formulations were well tolerated; pasireotide SC caused transient changes in glucose metabolism.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272710
04HumanNon-randomized trialSafety outcome
In Chinese healthy men, pasireotide LAR increased fasting blood glucose in a concentration-dependent manner.
In plain wordsIn Chinese healthy men, pasireotide LAR increased fasting blood glucose as drug concentrations increased.
Peptide
Pasireotide
Outcome
IncreaseFasting blood glucose with LAR
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
single IM dose of 20, 40, or 60 mg pasireotide LAR · intramuscular · single dose on day 33As given in this study (human).
Source sentences
Summary
Owing to the differential binding affinity to the somatostatin receptor subtypes, pasireotide LAR elicited a concentration-dependent increase of fasting blood glucose, substantial reduction in triglyceride, and a mild decrease in cholesterol.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272711
05HumanNon-randomized trialEfficacy outcome
In Chinese healthy men, pasireotide LAR substantially reduced triglycerides.
In plain wordsIn Chinese healthy men, pasireotide LAR substantially reduced triglycerides.
Peptide
Pasireotide
Outcome
DecreaseTriglycerides with LAR
Study
n: not reported in source
Outcome group
Lipids · Metabolic and weight
Studied dose
single IM dose of 20, 40, or 60 mg pasireotide LAR · intramuscular · single dose on day 33As given in this study (human).
Source sentences
Summary
Owing to the differential binding affinity to the somatostatin receptor subtypes, pasireotide LAR elicited a concentration-dependent increase of fasting blood glucose, substantial reduction in triglyceride, and a mild decrease in cholesterol.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272712
06HumanNon-randomized trialEfficacy outcome
In Chinese healthy men, pasireotide LAR mildly decreased cholesterol.
In plain wordsIn Chinese healthy men, pasireotide LAR mildly decreased cholesterol.
Peptide
Pasireotide
Outcome
DecreaseCholesterol with LAR
Study
n: not reported in source
Outcome group
Lipids · Metabolic and weight
Studied dose
single IM dose of 20, 40, or 60 mg pasireotide LAR · intramuscular · single dose on day 33As given in this study (human).
Source sentences
Summary
Owing to the differential binding affinity to the somatostatin receptor subtypes, pasireotide LAR elicited a concentration-dependent increase of fasting blood glucose, substantial reduction in triglyceride, and a mild decrease in cholesterol.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272713
07HumanNon-randomized trialSafety outcome
In Chinese healthy men, injection site reactions were frequent adverse events after single and multiple subcutaneous pasireotide doses.
In plain wordsIn Chinese healthy men, injection site reactions were frequent after single and repeated subcutaneous pasireotide doses.
Peptide
Pasireotide
Outcome
Not applicableInjection site reaction with SC formulation
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Studied dose
single SC dose of 300, 600, or 900 μg on day 1, then the same dose BID · subcutaneous · single dose on day 1, then BID from day 15 to the morning of day 19As given in this study (human).
Source sentences
Summary
The most frequently reported AEs after single-dose and multiple-dose pasireotide SC were injection site reaction, nausea, dizziness, and diarrhea; most HVs developed diarrhea with single-dose pasireotide LAR.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272714
08HumanNon-randomized trialSafety outcome
In Chinese healthy men, nausea was a frequent adverse event after single and multiple subcutaneous pasireotide doses.
In plain wordsIn Chinese healthy men, nausea was frequent after single and repeated subcutaneous pasireotide doses.
Peptide
Pasireotide
Outcome
Not applicableNausea with SC formulation
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
single SC dose of 300, 600, or 900 μg on day 1, then the same dose BID · subcutaneous · single dose on day 1, then BID from day 15 to the morning of day 19As given in this study (human).
Source sentences
Summary
The most frequently reported AEs after single-dose and multiple-dose pasireotide SC were injection site reaction, nausea, dizziness, and diarrhea; most HVs developed diarrhea with single-dose pasireotide LAR.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272715
09HumanNon-randomized trialSafety outcome
In Chinese healthy men, dizziness was a frequent adverse event after single and multiple subcutaneous pasireotide doses.
In plain wordsIn Chinese healthy men, dizziness was frequent after single and repeated subcutaneous pasireotide doses.
Peptide
Pasireotide
Outcome
Not applicableDizziness with SC formulation
Study
n: not reported in source
Outcome group
Adverse events · Nervous system and cognition
Studied dose
single SC dose of 300, 600, or 900 μg on day 1, then the same dose BID · subcutaneous · single dose on day 1, then BID from day 15 to the morning of day 19As given in this study (human).
Source sentences
Summary
The most frequently reported AEs after single-dose and multiple-dose pasireotide SC were injection site reaction, nausea, dizziness, and diarrhea; most HVs developed diarrhea with single-dose pasireotide LAR.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272716
10HumanNon-randomized trialSafety outcome
In Chinese healthy men, diarrhea was a frequent adverse event after single and multiple subcutaneous pasireotide doses.
In plain wordsIn Chinese healthy men, diarrhea was frequent after single and repeated subcutaneous pasireotide doses.
Peptide
Pasireotide
Outcome
Not applicableDiarrhea with SC formulation
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
single SC dose of 300, 600, or 900 μg on day 1, then the same dose BID · subcutaneous · single dose on day 1, then BID from day 15 to the morning of day 19As given in this study (human).
Source sentences
Summary
The most frequently reported AEs after single-dose and multiple-dose pasireotide SC were injection site reaction, nausea, dizziness, and diarrhea; most HVs developed diarrhea with single-dose pasireotide LAR.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272717
11HumanNon-randomized trialSafety outcome
In Chinese healthy men, most developed diarrhea after single-dose pasireotide LAR.
In plain wordsIn Chinese healthy men, most developed diarrhea after single-dose pasireotide LAR.
Peptide
Pasireotide
Outcome
Not applicableDiarrhea with single-dose LAR
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
single IM dose of 20, 40, or 60 mg pasireotide LAR · intramuscular · single dose on day 33As given in this study (human).
Source sentences
Summary
The most frequently reported AEs after single-dose and multiple-dose pasireotide SC were injection site reaction, nausea, dizziness, and diarrhea; most HVs developed diarrhea with single-dose pasireotide LAR.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272718
12HumanNon-randomized trialSafety outcome
In Chinese healthy men, subcutaneous pasireotide and intramuscular pasireotide LAR were well tolerated.
In plain wordsIn Chinese healthy men, both pasireotide formulations were well tolerated.
Peptide
Pasireotide
Outcome
Not applicableTolerability of both formulations
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
single SC dose of 300, 600, or 900 μg on day 1, then the same dose BID; single IM dose of 20, 40, or 60 mg pasireotide LAR on day 33 · subcutaneous and intramuscularAs given in this study (human).
Source sentences
Summary
Both formulations were well tolerated;
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences: each volunteer received a single dose of 300, 600, or 900 μg of pasireotide SC on day 1, followed by administration of the same dose BID from day 15 to the morning of day 19, a…
Report a problemFND-2501272719
13HumanObservational studyPharmacokinetics
In Chinese healthy men, concentration-time profiles of both pasireotide formulations resembled those in Western healthy volunteers.
In plain wordsIn Chinese healthy men, both pasireotide formulations had blood concentration profiles similar to those in Western healthy volunteers.
Peptide
Pasireotide
Outcome
Direction not reportedConcentration-time profiles
Study
n: not reported in source
Comparator
Western healthy volunteers from previous studies
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
single SC dose of 300, 600, or 900 μg on day 1, then the same dose BID; single IM dose of 20, 40, or 60 mg pasireotide LAR on day 33 · subcutaneous and intramuscularAs given in this study (human).
Source sentences
Summary
Concentration-time and safety profiles of both formulations were similar to those reported in Western HVs.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272702
14HumanObservational studySafety outcome
In Chinese healthy men, safety profiles of both pasireotide formulations resembled those in Western healthy volunteers.
In plain wordsIn Chinese healthy men, both pasireotide formulations had safety profiles similar to those in Western healthy volunteers.
Peptide
Pasireotide
Outcome
Direction not reportedSafety profiles
Study
n: not reported in source
Comparator
Western healthy volunteers from previous studies
Outcome group
Adverse events · Whole body
Studied dose
single SC dose of 300, 600, or 900 μg on day 1, then the same dose BID; single IM dose of 20, 40, or 60 mg pasireotide LAR on day 33 · subcutaneous and intramuscularAs given in this study (human).
Source sentences
Summary
Concentration-time and safety profiles of both formulations were similar to those reported in Western HVs.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272703
15HumanObservational studyPharmacokinetics
In Chinese versus Western healthy men, mean pasireotide PK geometric mean ratios ranged from 0.79 to 1.42.
In plain wordsIn Chinese versus Western healthy men, pasireotide PK ratios ranged from 0.79 to 1.42.
Peptide
Pasireotide
Outcome
MixedChinese-to-Western PK geometric mean ratios
Study
n: not reported in source
Comparator
Western healthy volunteers
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
single SC dose of 300, 600, or 900 μg on day 1, then the same dose BID; single IM dose of 20, 40, or 60 mg pasireotide LAR on day 33 · subcutaneous and intramuscularAs given in this study (human).
Measurements
Mean geometric mean ratio, Chinese versus Western HVs
0.79 to 1.42 ratio
mean GMRs across PK parameters
Source sentences
Summary
Mean geometric mean ratios (GMRs) of Chinese versus Western HVs ranged from 0.79 to 1.42.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272704
16HumanObservational studyPharmacokinetics
In Chinese versus Western healthy men, most primary pasireotide PK ratios had 90% CIs within the predefined 0.70-1.43 interval.
In plain wordsIn Chinese versus Western healthy men, most primary pasireotide PK ratios met the predefined ethnic insensitivity interval.
Peptide
Pasireotide
Outcome
Not applicablePrimary PK ethnic insensitivity interval
Study
n: not reported in source
Comparator
Western healthy volunteers
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
single SC dose of 300, 600, or 900 μg on day 1, then the same dose BID; single IM dose of 20, 40, or 60 mg pasireotide LAR on day 33 · subcutaneous and intramuscularAs given in this study (human).
Measurements
Predefined ethnic insensitivity interval for 90% CI of GMR
0.7 to 1.43 ratio
most primary PK parameters had 90% CIs within this interval
Source sentences
Summary
For most primary PK parameters, 90% CIs for GMRs were within a predefined ethnic insensitivity interval (90% CI, 0.70-1.43).
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272705
17HumanObservational studyPharmacokinetics
In Chinese versus Western healthy men, age- and weight-adjusted single-dose pasireotide Cmax ratios and CIs met the predefined interval.
In plain wordsIn Chinese versus Western healthy men, adjusted peak concentrations after a single subcutaneous pasireotide dose met the predefined interval.
Peptide
Pasireotide
Outcome
Not applicableAdjusted single-dose SC Cmax
Study
n: not reported in source
Comparator
Western healthy volunteers
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
single SC dose of 300, 600, or 900 μg · subcutaneous · single dose on day 1As given in this study (human).
Source sentences
Summary
After considering age and weight as covariates in the statistical model, the GMRs and 90% CIs for other PK parameters were within the predefined interval (Cmax in single-dose SC administration)
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272706
18HumanObservational studyPharmacokinetics
In Chinese versus Western healthy men, after adjustment for age and weight, the Cmin,ss geometric mean ratio and 90% CI for multiple BID subcutaneous pasireotide doses were reported as significantly decreased.
In plain wordsAfter age and weight adjustment, the Chinese-to-Western ratio for minimum steady-state pasireotide levels after twice-daily injections was reported as significantly decreased.
Peptide
Pasireotide
Outcome
DecreaseAdjusted multiple-dose SC Cmin,ss
Study
n: not reported in source
Comparator
Western healthy volunteers (pooled from previous PK studies)
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
same dose BID (300, 600, or 900 μg) · subcutaneous · BID from day 15 to the morning of day 19As given in this study (human).
Source sentences
Summary
After considering age and weight as covariates in the statistical model, the GMRs and 90% CIs for other PK parameters were within the predefined interval (Cmax in single-dose SC administration) or significantly decreased (Cmin,ss in multiple BID SC doses and first peak Cmax in the single-dose LAR formulation).
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272707
19HumanObservational studyPharmacokinetics
In Chinese versus Western healthy men, after adjustment for age and weight, the first-peak Cmax geometric mean ratio and 90% CI for single-dose pasireotide LAR were reported as significantly decreased.
In plain wordsIn healthy men, after adjusting for age and weight, the Chinese-to-Western ratio for the first peak of pasireotide LAR levels was reported as significantly decreased.
Peptide
Pasireotide
Outcome
DecreaseAdjusted single-dose LAR first peak Cmax
Study
n: not reported in source
Comparator
Western healthy volunteers (pooled from previous PK studies)
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
single IM dose of 20, 40, or 60 mg pasireotide LAR · intramuscular · single dose on day 33As given in this study (human).
Source sentences
Summary
After considering age and weight as covariates in the statistical model, the GMRs and 90% CIs for other PK parameters were within the predefined interval (Cmax in single-dose SC administration) or significantly decreased (Cmin,ss in multiple BID SC doses and first peak Cmax in the single-dose LAR formulation).
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties…
Summary · context
In this phase I, single-center, open-label study, 45 Chinese male HVs were evenly randomized to 1 to 9 treatment sequences:
Report a problemFND-2501272708

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Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

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Pharmacokinetics and safety of subcutaneous pasireotide and intramuscular pasireotide long-acting release in Chinese male healthy volunteers: a phase I, single-center, open-label, randomized study.

Summary

Results from this study19

Version history

Subjects

Publication types

MeSH terms

Keywords