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Study · Non-randomized trial · n = 12 · 2012

10 results

Safety, tolerability, and pharmacokinetics of a single dose of pasireotide long-acting release in healthy volunteers: a single-center Phase I study.

Dietrich H, Hu K, Ruffin M, Song D, Bouillaud E, Wang Y, Hasskarl J

European journal of endocrinology1 Mar 2012Cited by 26 (Europe PMC)

PMID22383336 (opens in a new tab)DOI10.1530/eje-11-0773 (opens in a new tab)PepBankPUB-22383336
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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 study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide LAR released over 1 month, with concentration peaks 1 and around 20 days after injection.

    In plain wordsIn healthy men, pasireotide LAR released over one month with two concentration peaks.

    Peptide
    Pasireotide
    Outcome
    Not applicableExtended release and concentration peaks
    Study

    n = 12

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    40 or 60 mg single dose · intramuscularAs given in this study (human).

    Measurements

    Extended-release profile duration
    1 month
    pasireotide LAR single i.m. dose
    Time of first concentration peak
    1 days after injection
    pasireotide LAR
    Time of second concentration peak
    ≈ 20 days after injection
    pasireotide LAR

    Source sentences

    Summary
    Pasireotide LAR showed an extended-release profile over 1 month with two concentration peaks observed 1 and around 20 days after injection.
    2 context sentences
    Summary · context
    Single-center, open-label, randomized Phase I study.
    Summary · context
    Twelve healthy male subjects received a single s.c. dose of pasireotide 300 μg followed by a washout period of 7 days (or at least 5 days), before receiving an i.m. injection of pasireotide -LAR 40 mg (n=5) or 60 mg (n=7).
  2. 02HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide LAR AUC exposure was dose proportional between the tested doses.

    In plain wordsIn healthy men, pasireotide LAR exposure increased in proportion to dose.

    Peptide
    Pasireotide
    Outcome
    IncreaseAUC dose proportionality
    Study

    n = 12

    Comparator
    pasireotide LAR 40 mg versus 60 mg dose levels
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    40 or 60 mg single dose · intramuscularAs given in this study (human).

    Source sentences

    Summary
    The area under curve exposure of pasireotide LAR was dose proportional when the dose levels were compared, and the bioavailability of the LAR relative to the s.c. formulation was complete.
    2 context sentences
    Summary · context
    Single-center, open-label, randomized Phase I study.
    Summary · context
    Twelve healthy male subjects received a single s.c. dose of pasireotide 300 μg followed by a washout period of 7 days (or at least 5 days), before receiving an i.m. injection of pasireotide -LAR 40 mg (n=5) or 60 mg (n=7).
  3. 03HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide LAR bioavailability relative to the subcutaneous formulation was complete.

    In plain wordsIn healthy men, pasireotide LAR had complete bioavailability relative to the subcutaneous formulation.

    Peptide
    Pasireotide
    Outcome
    Not applicableRelative bioavailability
    Study

    n = 12

    Comparator
    subcutaneous pasireotide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    pasireotide LAR 40 or 60 mg single i.m. dose versus 300 μg single s.c. dose · intramuscular (LAR) versus subcutaneous (reference)As given in this study (human).

    Source sentences

    Summary
    The area under curve exposure of pasireotide LAR was dose proportional when the dose levels were compared, and the bioavailability of the LAR relative to the s.c. formulation was complete.
    2 context sentences
    Summary · context
    Single-center, open-label, randomized Phase I study.
    Summary · context
    Twelve healthy male subjects received a single s.c. dose of pasireotide 300 μg followed by a washout period of 7 days (or at least 5 days), before receiving an i.m. injection of pasireotide -LAR 40 mg (n=5) or 60 mg (n=7).
  4. 04HumanNon-randomized trialSafety outcome

    In healthy men, pasireotide LAR increased fasting glucose.

    In plain wordsIn healthy men, fasting blood sugar increased after pasireotide LAR.

    Peptide
    Pasireotide
    Outcome
    IncreaseFasting glucose
    Study

    n = 12

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    40 or 60 mg single dose · intramuscularAs given in this study (human).

    Source sentences

    Summary
    Administration of pasireotide LAR resulted in an increase in fasting and postprandial glucose levels; however, an attenuation of the hyperglycemic effect was observed after 15 days.
    2 context sentences
    Summary · context
    Single-center, open-label, randomized Phase I study.
    Summary · context
    Twelve healthy male subjects received a single s.c. dose of pasireotide 300 μg followed by a washout period of 7 days (or at least 5 days), before receiving an i.m. injection of pasireotide -LAR 40 mg (n=5) or 60 mg (n=7).
  5. 05HumanNon-randomized trialSafety outcome

    In healthy men, pasireotide LAR increased postprandial glucose.

    In plain wordsIn healthy men, blood sugar after meals increased after pasireotide LAR.

    Peptide
    Pasireotide
    Outcome
    IncreasePostprandial glucose
    Study

    n = 12

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    40 or 60 mg single dose · intramuscularAs given in this study (human).

    Source sentences

    Summary
    Administration of pasireotide LAR resulted in an increase in fasting and postprandial glucose levels; however, an attenuation of the hyperglycemic effect was observed after 15 days.
    2 context sentences
    Summary · context
    Single-center, open-label, randomized Phase I study.
    Summary · context
    Twelve healthy male subjects received a single s.c. dose of pasireotide 300 μg followed by a washout period of 7 days (or at least 5 days), before receiving an i.m. injection of pasireotide -LAR 40 mg (n=5) or 60 mg (n=7).
  6. 06HumanNon-randomized trialSafety outcome

    In healthy men, the hyperglycemic effect of pasireotide LAR attenuated after 15 days.

    In plain wordsIn healthy men, the blood sugar effect of pasireotide LAR weakened after 15 days.

    Peptide
    Pasireotide
    Outcome
    DecreaseHyperglycemic effect attenuation
    Study

    n = 12

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    40 or 60 mg single dose · intramuscularAs given in this study (human).

    Measurements

    Time after which hyperglycemic effect was attenuated
    15 days
    pasireotide LAR, healthy men

    Source sentences

    Summary
    Administration of pasireotide LAR resulted in an increase in fasting and postprandial glucose levels; however, an attenuation of the hyperglycemic effect was observed after 15 days.
    2 context sentences
    Summary · context
    Single-center, open-label, randomized Phase I study.
    Summary · context
    Twelve healthy male subjects received a single s.c. dose of pasireotide 300 μg followed by a washout period of 7 days (or at least 5 days), before receiving an i.m. injection of pasireotide -LAR 40 mg (n=5) or 60 mg (n=7).
  7. 07HumanNon-randomized trialSafety outcome

    In healthy men receiving pasireotide LAR, mild-to-moderate diarrhea was among the most frequent adverse events.

    In plain wordsHealthy men receiving pasireotide LAR frequently reported mild-to-moderate diarrhea.

    Peptide
    Pasireotide
    Outcome
    Not applicableDiarrhea
    Study

    n = 12

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    40 or 60 mg single dose · intramuscularAs given in this study (human).

    Source sentences

    Summary
    The most frequently reported AEs were mild-to-moderate diarrhea, abdominal pain, and flatulence.
    2 context sentences
    Summary · context
    Single-center, open-label, randomized Phase I study.
    Summary · context
    Twelve healthy male subjects received a single s.c. dose of pasireotide 300 μg followed by a washout period of 7 days (or at least 5 days), before receiving an i.m. injection of pasireotide -LAR 40 mg (n=5) or 60 mg (n=7).
  8. 08HumanNon-randomized trialSafety outcome

    In healthy men receiving pasireotide LAR, mild-to-moderate abdominal pain was among the most frequent adverse events.

    In plain wordsHealthy men receiving pasireotide LAR frequently reported mild-to-moderate abdominal pain.

    Peptide
    Pasireotide
    Outcome
    Not applicableAbdominal pain
    Study

    n = 12

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    40 or 60 mg single dose · intramuscularAs given in this study (human).

    Source sentences

    Summary
    The most frequently reported AEs were mild-to-moderate diarrhea, abdominal pain, and flatulence.
    2 context sentences
    Summary · context
    Single-center, open-label, randomized Phase I study.
    Summary · context
    Twelve healthy male subjects received a single s.c. dose of pasireotide 300 μg followed by a washout period of 7 days (or at least 5 days), before receiving an i.m. injection of pasireotide -LAR 40 mg (n=5) or 60 mg (n=7).
  9. 09HumanNon-randomized trialSafety outcome

    In healthy men receiving pasireotide LAR, mild-to-moderate flatulence was among the most frequent adverse events.

    In plain wordsHealthy men receiving pasireotide LAR frequently reported mild-to-moderate flatulence.

    Peptide
    Pasireotide
    Outcome
    Not applicableFlatulence
    Study

    n = 12

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    40 or 60 mg single dose · intramuscularAs given in this study (human).

    Source sentences

    Summary
    The most frequently reported AEs were mild-to-moderate diarrhea, abdominal pain, and flatulence.
    2 context sentences
    Summary · context
    Single-center, open-label, randomized Phase I study.
    Summary · context
    Twelve healthy male subjects received a single s.c. dose of pasireotide 300 μg followed by a washout period of 7 days (or at least 5 days), before receiving an i.m. injection of pasireotide -LAR 40 mg (n=5) or 60 mg (n=7).
  10. 10HumanNon-randomized trialSafety outcome

    In healthy men receiving pasireotide LAR, injection site reactions were suspected to be drug related.

    In plain wordsIn healthy men, injection site reactions were suspected side effects of pasireotide LAR.

    Peptide
    Pasireotide
    Outcome
    Not applicableInjection site reactions
    Study

    n = 12

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    40 or 60 mg single dose · intramuscularAs given in this study (human).

    Source sentences

    Summary
    Only gastrointestinal AEs and injection site reactions were suspected to be drug related.
    2 context sentences
    Summary · context
    Single-center, open-label, randomized Phase I study.
    Summary · context
    Twelve healthy male subjects received a single s.c. dose of pasireotide 300 μg followed by a washout period of 7 days (or at least 5 days), before receiving an i.m. injection of pasireotide -LAR 40 mg (n=5) or 60 mg (n=7).

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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