Population Pharmacokinetics of Subcutaneous Pasireotide in Healthy Volunteers and Cushing's Disease Patients.

Nedelman J, Fisch R, Hu K, Paule I, Zhou J

Clinical pharmacokinetics1 Jul 2018Cited by 3 (Europe PMC)

PMID29032486DOI10.1007/s40262-017-0600-yPepBankPUB-29032486

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanObservational studyPharmacokinetics
In Cushing's disease patients, estimated apparent pasireotide clearance was 59% of that in healthy volunteers of the same age and body size.
In plain wordsIn Cushing's disease patients, estimated pasireotide clearance was lower than in healthy volunteers of the same age and body size.
Peptide
Pasireotide
Outcome
DecreaseApparent clearance relative to healthy volunteers
Study
n: not reported in source
Comparator
Healthy volunteers at the same age and body size
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Apparent clearance (CL/F) in Cushing's disease patients relative to healthy volunteers
59 % of healthy volunteers
same age and body size
Source sentences
Summary
In the final model, the estimated values of apparent clearance (CL/F), central volume of distribution, and deep peripheral volume of distribution of pasireotide in CDP were 59, 43, and 225% those of HVs at the same age and body size.
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis characterizes the population pharmacokinetics (PopPK) of subcutaneous pasireotide jointly in healthy volunteers (HVs) and Cushing's disease patients (CDPs), evaluating the effects of age, body size, and population on pasireotide pharmacokinetics.
Summary · context
The analysis dataset included five phase I studies and one each from phase II and phase III.
Summary · context
A three-compartment, linear structural pharmacokinetic model was used.
Report a problemFND-2903248601
02HumanObservational studyPharmacokinetics
In Cushing's disease patients, estimated central pasireotide distribution volume was 43% of that in healthy volunteers of the same age and body size.
In plain wordsIn Cushing's disease patients, estimated central pasireotide distribution volume was lower than in comparable healthy volunteers.
Peptide
Pasireotide
Outcome
DecreaseCentral volume of distribution
Study
n: not reported in source
Comparator
Healthy volunteers at the same age and body size
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Central volume of distribution in Cushing's disease patients relative to healthy volunteers
43 % of healthy volunteers
same age and body size
Source sentences
Summary
In the final model, the estimated values of apparent clearance (CL/F), central volume of distribution, and deep peripheral volume of distribution of pasireotide in CDP were 59, 43, and 225% those of HVs at the same age and body size.
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis characterizes the population pharmacokinetics (PopPK) of subcutaneous pasireotide jointly in healthy volunteers (HVs) and Cushing's disease patients (CDPs), evaluating the effects of age, body size, and population on pasireotide pharmacokinetics.
Summary · context
The analysis dataset included five phase I studies and one each from phase II and phase III.
Summary · context
A three-compartment, linear structural pharmacokinetic model was used.
Report a problemFND-2903248602
03HumanObservational studyPharmacokinetics
In Cushing's disease patients, estimated deep peripheral pasireotide distribution volume was 225% of that in healthy volunteers of the same age and body size.
In plain wordsIn Cushing's disease patients, estimated deep peripheral pasireotide distribution volume was higher than in comparable healthy volunteers.
Peptide
Pasireotide
Outcome
IncreaseDeep peripheral volume of distribution
Study
n: not reported in source
Comparator
Healthy volunteers at the same age and body size
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Deep peripheral volume of distribution in Cushing's disease patients relative to healthy volunteers
225 % of healthy volunteers
same age and body size
Source sentences
Summary
In the final model, the estimated values of apparent clearance (CL/F), central volume of distribution, and deep peripheral volume of distribution of pasireotide in CDP were 59, 43, and 225% those of HVs at the same age and body size.
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis characterizes the population pharmacokinetics (PopPK) of subcutaneous pasireotide jointly in healthy volunteers (HVs) and Cushing's disease patients (CDPs), evaluating the effects of age, body size, and population on pasireotide pharmacokinetics.
Summary · context
The analysis dataset included five phase I studies and one each from phase II and phase III.
Summary · context
A three-compartment, linear structural pharmacokinetic model was used.
Report a problemFND-2903248603
04HumanObservational studyPharmacokinetics
In Cushing's disease patients and healthy volunteers, pasireotide clearance increased with body size similarly in both populations.
In plain wordsIn patients and healthy volunteers, larger body size was linked to higher pasireotide clearance.
Peptide
Pasireotide
Outcome
IncreaseClearance association with body size
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
Clearance increased with body size and decreased with age similarly for CDPs and HVs.
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis characterizes the population pharmacokinetics (PopPK) of subcutaneous pasireotide jointly in healthy volunteers (HVs) and Cushing's disease patients (CDPs), evaluating the effects of age, body size, and population on pasireotide pharmacokinetics.
Summary · context
The analysis dataset included five phase I studies and one each from phase II and phase III.
Summary · context
A three-compartment, linear structural pharmacokinetic model was used.
Report a problemFND-2903248604
05HumanObservational studyPharmacokinetics
In Cushing's disease patients and healthy volunteers, pasireotide clearance decreased with age similarly in both populations.
In plain wordsIn patients and healthy volunteers, older age was linked to lower pasireotide clearance.
Peptide
Pasireotide
Outcome
DecreaseClearance association with age
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
Clearance increased with body size and decreased with age similarly for CDPs and HVs.
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis characterizes the population pharmacokinetics (PopPK) of subcutaneous pasireotide jointly in healthy volunteers (HVs) and Cushing's disease patients (CDPs), evaluating the effects of age, body size, and population on pasireotide pharmacokinetics.
Summary · context
The analysis dataset included five phase I studies and one each from phase II and phase III.
Summary · context
A three-compartment, linear structural pharmacokinetic model was used.
Report a problemFND-2903248605
06HumanObservational studyPharmacokinetics
For a typical Cushing's disease patient aged 40 years with lean body weight 49 kg, estimated pasireotide apparent clearance was 3.72 L/h.
In plain wordsIn a typical Cushing's disease patient, estimated pasireotide clearance was 3.72 L/h.
Peptide
Pasireotide
Outcome
Not applicableTypical patient apparent clearance
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Estimated apparent clearance (CL/F)
3.72 L/h
typical Cushing's disease patient (40 years, lean body weight 49 kg)
Source sentences
Summary
The estimated CL/F for a typical CDP (40 years old, lean body weight [LBW] 49 kg) was 3.72 L/h, and for a typical HV (29 years old, LBW 61 kg) was 7.96 L/h.
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis characterizes the population pharmacokinetics (PopPK) of subcutaneous pasireotide jointly in healthy volunteers (HVs) and Cushing's disease patients (CDPs), evaluating the effects of age, body size, and population on pasireotide pharmacokinetics.
Summary · context
The analysis dataset included five phase I studies and one each from phase II and phase III.
Summary · context
A three-compartment, linear structural pharmacokinetic model was used.
Report a problemFND-2903248606
07HumanObservational studyPharmacokinetics
For a typical healthy volunteer aged 29 years with lean body weight 61 kg, estimated pasireotide apparent clearance was 7.96 L/h.
In plain wordsIn a typical healthy volunteer, estimated pasireotide clearance was 7.96 L/h.
Peptide
Pasireotide
Outcome
Not applicableTypical healthy volunteer apparent clearance
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Estimated apparent clearance (CL/F)
7.96 L/h
typical healthy volunteer (29 years, lean body weight 61 kg)
Source sentences
Summary
The estimated CL/F for a typical CDP (40 years old, lean body weight [LBW] 49 kg) was 3.72 L/h, and for a typical HV (29 years old, LBW 61 kg) was 7.96 L/h.
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis characterizes the population pharmacokinetics (PopPK) of subcutaneous pasireotide jointly in healthy volunteers (HVs) and Cushing's disease patients (CDPs), evaluating the effects of age, body size, and population on pasireotide pharmacokinetics.
Summary · context
The analysis dataset included five phase I studies and one each from phase II and phase III.
Summary · context
A three-compartment, linear structural pharmacokinetic model was used.
Report a problemFND-2903248607

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

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

Subjects

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