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Study · Randomized controlled trial · 2013

3 results

Impact of Tesamorelin, a Growth Hormone-Releasing Factor (GRF) Analogue, on the Pharmacokinetics of Simvastatin and Ritonavir in Healthy Volunteers.

Teng S, Potvin D, Mamputu JC, Vincent G, Zoltowska M, Morin J, Hatimi S, Michaud SE, High K, Ducharme MP

Clinical pharmacology in drug development15 May 2013Cited by 2 (Europe PMC)

PMID27121785 (opens in a new tab)DOI10.1002/cpdd.27 (opens in a new tab)PepBankPUB-27121785
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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 study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, tesamorelin did not change simvastatin exposure: AUC and Cmax ratios stayed within the usual no-effect range.

    In plain wordsIn healthy volunteers, tesamorelin did not change how much simvastatin the body took up, compared with simvastatin alone.

    Peptide
    Tesamorelin
    Outcome
    No significant changeSimvastatin AUC and Cmax with tesamorelin
    Study

    n: not reported in source

    Comparator
    Simvastatin alone
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    2 mg · 7 daysAs given in this study (human).

    Source sentences

    Summary
    For simvastatin, A/B ratios of least squares geometric means and corresponding 90% confidence intervals (CIs) for AUC0-t , AUC0-inf and Cmax were contained within the usual no effect range of 80-125%.
    1 context sentence
    Summary · context
    In two randomized, two-way crossover studies, subjects were administered 2 mg tesamorelin on Days 1-7 with 80 mg simvastatin or 100 mg ritonavir co-administered on Day 6 (Treatment A), and a single dose of simvastatin or ritonavir alone on Day 6 (Treatment B).
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, tesamorelin did not change ritonavir AUC: ratios and 90% CIs were within the acceptance range.

    In plain wordsIn healthy volunteers, tesamorelin did not change how much ritonavir the body took up, compared with ritonavir alone.

    Peptide
    Tesamorelin
    Outcome
    No significant changeRitonavir AUC with tesamorelin
    Study

    n: not reported in source

    Comparator
    Ritonavir alone
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    2 mg · 7 daysAs given in this study (human).

    Source sentences

    Summary
    For ritonavir, ratios and 90% CIs for AUCs were within this acceptance range
    1 context sentence
    Summary · context
    In two randomized, two-way crossover studies, subjects were administered 2 mg tesamorelin on Days 1-7 with 80 mg simvastatin or 100 mg ritonavir co-administered on Day 6 (Treatment A), and a single dose of simvastatin or ritonavir alone on Day 6 (Treatment B).
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, the lower 90% CI of the ritonavir Cmax ratio with tesamorelin was 74.8%, a minor decrease in rate of exposure.

    In plain wordsIn healthy volunteers, tesamorelin slightly lowered the peak ritonavir level compared with ritonavir alone; the authors call this a minor decrease.

    Peptide
    Tesamorelin
    Outcome
    DecreaseRitonavir Cmax with tesamorelin
    Study

    n: not reported in source

    Comparator
    Ritonavir alone
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    2 mg · 7 daysAs given in this study (human).

    Measurements

    Lower 90% CI of Cmax A/B ratio
    74.8%
    ritonavir

    Source sentences

    Summary
    but the lower CI for Cmax was 74.8%, suggesting a decreased rate of exposure.
    2 context sentences
    Summary · context
    since the A/B ratios for AUCs and Cmax parameters were approximately 90%, these were minor decreases
    Summary · context
    In two randomized, two-way crossover studies, subjects were administered 2 mg tesamorelin on Days 1-7 with 80 mg simvastatin or 100 mg ritonavir co-administered on Day 6 (Treatment A), and a single dose of simvastatin or ritonavir alone on Day 6 (Treatment B).

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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

    9 Oct 2026, 19:08 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:13 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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