Skip to content

Study · Non-randomized trial · n = 20 · 2025

4 results

Physiologically-Based Pharmacokinetic Modeling of Trofinetide in Moderate Renal Impairment for Phase 1 Clinical Study Dose Selection with Model Validation.

Darwish M, Marbury TC, Nunez R, Youakim JM, An D, Darling I, Lukacova V, Bishop KM

European journal of drug metabolism and pharmacokinetics8 Nov 2024Cited by 2 (Europe PMC)

PMID39516357 (opens in a new tab)PMCIDPMC11802684 (opens in a new tab)DOI10.1007/s13318-024-00924-1 (opens in a new tab)PepBankPUB-39516357
Read at sourcePubMedAsk about this study
Jump to 4 results

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. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanNon-randomized trialPharmacokinetics

    After trofinetide, moderate renal impairment participants had comparable dose-normalized maximum concentration to healthy controls, with a geometric mean ratio of 1.02.

    In plain wordsAfter trofinetide, dose-normalized peak concentrations were comparable in participants with moderate renal impairment and healthy controls.

    Peptide
    Trofinetide
    Outcome
    Direction not reportedDose-normalized maximum concentration
    Study

    n = 20

    Comparator
    Healthy participants receiving 12 g
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    6 g in moderate renal impairment; 12 g in healthy participants · oral · single doseAs given in this study (human).

    Measurements

    Cmax geometric mean ratio
    1.02 ratio
    90% CI 0.69-1.50

    Source sentences

    Summary
    Dose-normalized geometric mean ratios for Cmax were comparable [1.02 (90% CI 0.69-1.50)] while AUCinf was approximately two-fold higher [1.81 (90% CI 1.31-2.50)] in moderate renal impairment participants compared with healthy controls.
    1 context sentence
    Summary · context
    In a phase 1, open-label study, trofinetide exposure was assessed in healthy (n = 10) and moderate renal impairment (n = 10) participants receiving single oral doses of 12 g or 6 g, respectively.
  2. 02HumanNon-randomized trialPharmacokinetics

    After trofinetide, moderate renal impairment participants had higher dose-normalized AUC than healthy controls, with a geometric mean ratio of 1.81.

    In plain wordsAfter trofinetide, dose-normalized total exposure was higher in participants with moderate renal impairment than healthy controls.

    Peptide
    Trofinetide
    Outcome
    IncreaseDose-normalized AUC to infinity
    Study

    n = 20

    Comparator
    Healthy participants receiving 12 g
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    6 g in moderate renal impairment; 12 g in healthy participants · oral · single doseAs given in this study (human).

    Measurements

    AUCinf geometric mean ratio
    1.81 ratio
    90% CI 1.31-2.50

    Source sentences

    Summary
    Dose-normalized geometric mean ratios for Cmax were comparable [1.02 (90% CI 0.69-1.50)] while AUCinf was approximately two-fold higher [1.81 (90% CI 1.31-2.50)] in moderate renal impairment participants compared with healthy controls.
    1 context sentence
    Summary · context
    In a phase 1, open-label study, trofinetide exposure was assessed in healthy (n = 10) and moderate renal impairment (n = 10) participants receiving single oral doses of 12 g or 6 g, respectively.
  3. 03HumanNon-randomized trialSafety outcome

    After single-dose trofinetide, two participants with moderate renal impairment reported treatment-emergent adverse events, representing 20.0%.

    In plain wordsAfter single-dose trofinetide, 20.0% of participants with moderate renal impairment reported adverse events.

    Peptide
    Trofinetide
    Outcome
    Not applicableTreatment-emergent adverse events in moderate renal impairment
    Study

    n = 10

    Outcome group
    Adverse events · Whole body
    Studied dose
    6 g · oral · single doseAs given in this study (human).

    Measurements

    Participants with TEAEs
    2 participants
    moderate renal impairment
    TEAE incidence
    20%
    moderate renal impairment

    Source sentences

    Summary
    Treatment-emergent adverse events were reported in two (20.0%) participants with moderate renal impairment and four healthy participants (40.0%).
    1 context sentence
    Summary · context
    In a phase 1, open-label study, trofinetide exposure was assessed in healthy (n = 10) and moderate renal impairment (n = 10) participants receiving single oral doses of 12 g or 6 g, respectively.
  4. 04HumanNon-randomized trialSafety outcome

    After single-dose trofinetide, four healthy participants reported treatment-emergent adverse events, representing 40.0%.

    In plain wordsAfter single-dose trofinetide, 40.0% of healthy participants reported adverse events.

    Peptide
    Trofinetide
    Outcome
    Not applicableTreatment-emergent adverse events in healthy participants
    Study

    n = 10

    Outcome group
    Adverse events · Whole body
    Studied dose
    12 g · oral · single doseAs given in this study (human).

    Measurements

    Participants with TEAEs
    4 participants
    healthy participants
    TEAE incidence
    40%
    healthy participants

    Source sentences

    Summary
    Treatment-emergent adverse events were reported in two (20.0%) participants with moderate renal impairment and four healthy participants (40.0%).
    1 context sentence
    Summary · context
    In a phase 1, open-label study, trofinetide exposure was assessed in healthy (n = 10) and moderate renal impairment (n = 10) participants receiving single oral doses of 12 g or 6 g, respectively.

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, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.