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Study · Non-randomized trial · n = 14 · 2013

7 results

Pegvisomant bioavailability of single 30 mg/mL subcutaneous injection compared to two 15 mg/mL subcutaneous injections: a pharmacokinetic, safety and tolerability study.

Jen J, LaBadie RR, Liang Y, Crownover PH, Gao X, Hey-Hadavi JH

Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society4 May 2013Cited by 1 (Europe PMC)

PMID23651793 (opens in a new tab)DOI10.1016/j.ghir.2013.04.002 (opens in a new tab)PepBankPUB-23651793
Publisher pagePubMedAsk about this study
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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 study7

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

  1. 01HumanNon-randomized trialPharmacokinetics

    In healthy adults, pegvisomant relative bioavailability was 123.89% for one concentrated injection versus two injections, with 90% CI 112.91-135.93%.

    In plain wordsIn healthy adults, one concentrated pegvisomant injection had higher relative bioavailability than two less concentrated injections.

    Peptide
    Pegvisomant
    Outcome
    IncreaseRelative bioavailability
    Study

    n = 14

    Comparator
    Two injections of 15 mg/mL
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    One injection of 30 mg/mL · subcutaneous · single doseAs given in this study (human).

    Measurements

    Relative bioavailability
    123.89%
    1 × 30 mg/mL relative to 2 × 15 mg/mL
    90% CI of relative bioavailability
    112.91 to 135.93%
    1 × 30 mg/mL relative to 2 × 15 mg/mL

    Source sentences

    Summary
    The relBA of 1 × 30 mg/mL relative to 2 × 15 mg/mL was 123.89% with a 90% CI (112.91-135.93%).
    2 context sentences
    Summary · context
    This was a 2-period, single-dose, crossover study in 14 healthy male and female subjects.
    Summary · context
    All subjects received both administrations during the two treatment periods separated by a two-week washout.
  2. 02HumanNon-randomized trialPharmacokinetics

    In healthy adults, dose-adjusted pegvisomant relative bioavailability was 112.97% for one injection versus two, with 90% CI 103.09-123.80%.

    In plain wordsIn healthy adults, one concentrated pegvisomant injection had higher dose-adjusted bioavailability than two less concentrated injections.

    Peptide
    Pegvisomant
    Outcome
    IncreaseDose-adjusted relative bioavailability
    Study

    n = 14

    Comparator
    Two injections of 15 mg/mL
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    One injection of 30 mg/mL · subcutaneous · single doseAs given in this study (human).

    Measurements

    Dose-adjusted relative bioavailability
    112.97%
    1 × 30 mg/mL relative to 2 × 15 mg/mL
    90% CI of dose-adjusted relative bioavailability
    103.09 to 123.8%
    1 × 30 mg/mL relative to 2 × 15 mg/mL

    Source sentences

    Summary
    Adjusted for the difference in actual pegvisomant amounts in both formulations the dose-adjusted relBA reduced to 112.97% with a 90% CI (103.09-123.80%).
    3 context sentences
    Summary · context
    The relBA of 1 × 30 mg/mL relative to 2 × 15 mg/mL was 123.89% with a 90% CI (112.91-135.93%).
    Summary · context
    This was a 2-period, single-dose, crossover study in 14 healthy male and female subjects.
    Summary · context
    All subjects received both administrations during the two treatment periods separated by a two-week washout.
  3. 03HumanNon-randomized trialPharmacokinetics

    In healthy adults, other pegvisomant pharmacokinetic parameters were comparable between one concentrated injection and two less concentrated injections.

    In plain wordsIn healthy adults, other pegvisomant pharmacokinetic measures were comparable between one concentrated injection and two less concentrated injections.

    Peptide
    Pegvisomant
    Outcome
    No significant changeOther pharmacokinetic parameters
    Study

    n = 14

    Comparator
    Two injections of 15 mg/mL
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    One injection of 30 mg/mL · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Other PK parameters for the two administrations were comparable.
    2 context sentences
    Summary · context
    This was a 2-period, single-dose, crossover study in 14 healthy male and female subjects.
    Summary · context
    All subjects received both administrations during the two treatment periods separated by a two-week washout.
  4. 04HumanNon-randomized trialSafety outcome

    In healthy adults, neither pegvisomant administration produced laboratory abnormalities of clinical concern.

    In plain wordsIn healthy adults, neither pegvisomant injection regimen produced laboratory abnormalities of clinical concern.

    Peptide
    Pegvisomant
    Outcome
    Not applicableLaboratory abnormalities of clinical concern
    Study

    n = 14

    Outcome group
    Adverse events · Whole body
    Studied dose
    One injection of 30 mg/mL and two injections of 15 mg/mL · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    No laboratory abnormalities, vital signs, ECG, or injection site reactions of clinical concern were observed in either treatment.
    2 context sentences
    Summary · context
    This was a 2-period, single-dose, crossover study in 14 healthy male and female subjects.
    Summary · context
    All subjects received both administrations during the two treatment periods separated by a two-week washout.
  5. 05HumanNon-randomized trialSafety outcome

    In healthy adults, neither pegvisomant administration produced vital sign findings of clinical concern.

    In plain wordsIn healthy adults, neither pegvisomant injection regimen produced vital sign findings of clinical concern.

    Peptide
    Pegvisomant
    Outcome
    Not applicableVital signs of clinical concern
    Study

    n = 14

    Outcome group
    Adverse events · Whole body
    Studied dose
    One injection of 30 mg/mL and two injections of 15 mg/mL · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    No laboratory abnormalities, vital signs, ECG, or injection site reactions of clinical concern were observed in either treatment.
    2 context sentences
    Summary · context
    This was a 2-period, single-dose, crossover study in 14 healthy male and female subjects.
    Summary · context
    All subjects received both administrations during the two treatment periods separated by a two-week washout.
  6. 06HumanNon-randomized trialSafety outcome

    In healthy adults, neither pegvisomant administration produced ECG findings of clinical concern.

    In plain wordsIn healthy adults, neither pegvisomant injection regimen produced ECG findings of clinical concern.

    Peptide
    Pegvisomant
    Outcome
    Not applicableECG findings of clinical concern
    Study

    n = 14

    Outcome group
    Adverse events · Cardiovascular
    Studied dose
    One injection of 30 mg/mL and two injections of 15 mg/mL · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    No laboratory abnormalities, vital signs, ECG, or injection site reactions of clinical concern were observed in either treatment.
    2 context sentences
    Summary · context
    This was a 2-period, single-dose, crossover study in 14 healthy male and female subjects.
    Summary · context
    All subjects received both administrations during the two treatment periods separated by a two-week washout.
  7. 07HumanNon-randomized trialSafety outcome

    In healthy adults, neither pegvisomant administration produced injection site reactions of clinical concern.

    In plain wordsIn healthy adults, neither pegvisomant injection regimen produced injection site reactions of clinical concern.

    Peptide
    Pegvisomant
    Outcome
    Not applicableInjection site reactions of clinical concern
    Study

    n = 14

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    One injection of 30 mg/mL and two injections of 15 mg/mL · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    No laboratory abnormalities, vital signs, ECG, or injection site reactions of clinical concern were observed in either treatment.
    2 context sentences
    Summary · context
    This was a 2-period, single-dose, crossover study in 14 healthy male and female subjects.
    Summary · context
    All subjects received both administrations during the two treatment periods separated by a two-week washout.

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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