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Study · Randomized controlled trial · n = 41 · 2022

8 results

A Phase 1, Open-Label Study to Evaluate the Effects of Food and Evening Dosing on the Pharmacokinetics of Oral Trofinetide in Healthy Adult Subjects.

Darwish M, Youakim JM, Harlick J, DeKarske D, Stankovic S

Clinical drug investigation27 May 2022Cited by 13 (Europe PMC)

PMID35622206 (opens in a new tab)PMCIDPMC9188616 (opens in a new tab)DOI10.1007/s40261-022-01156-4 (opens in a new tab)PepBankPUB-35622206
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy adults, morning fed trofinetide met AUC bioequivalence criteria versus morning fasted dosing.

    In plain wordsIn healthy adults, trofinetide met total-exposure equivalence criteria after morning dosing with food versus without food.

    Peptide
    Trofinetide
    Outcome
    Not applicableAUC bioequivalence, food effect
    Study

    n = 41

    Comparator
    Morning fasted dosing
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    12 g (60 mL oral solution) · oralAs given in this study (human).

    Source sentences

    Summary
    Bioequivalence criteria were met for all conditions (i.e., morning fed vs. morning fasted and evening fasted vs. morning fasted) except Cmax in the fed versus fasted condition, which was just below the bioequivalence limit (75.49%), suggesting a negligible food effect and lack of diurnal…
    3 context sentences
    Summary · context
    Bioequivalence was confirmed if 90% confidence intervals for geometric mean ratio between B/A or C/A fell within 80-125% equivalence limits for area under the concentration-time curve (AUC) and maximum concentration (Cmax) in whole blood.
    Summary · context
    A 60 mL oral solution of trofinetide (12 g) was administered in three dosing periods: morning fasted (A; reference), morning fed (B), and evening fasted (C).
    Summary · context
    Healthy adult subjects (18-45 years) were randomized to sequence ABC (n = 19) or BAC (n = 22).
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy adults, the Cmax of morning fed trofinetide versus morning fasted dosing was just below the bioequivalence limit (75.49%), the only criterion not met.

    In plain wordsIn healthy adults, peak trofinetide levels after food were just below the equivalence limit (75.49%) compared with fasting, the only measure not met.

    Peptide
    Trofinetide
    Outcome
    Not applicableCmax bioequivalence, food effect
    Study

    n = 41

    Comparator
    Morning fasted dosing
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    12 g (60 mL oral solution) · oralAs given in this study (human).

    Measurements

    Cmax fed versus fasted, reported just below the bioequivalence limit
    75.49%
    morning fed versus morning fasted

    Source sentences

    Summary
    Bioequivalence criteria were met for all conditions (i.e., morning fed vs. morning fasted and evening fasted vs. morning fasted) except Cmax in the fed versus fasted condition, which was just below the bioequivalence limit (75.49%), suggesting a negligible food effect and lack of diurnal…
    3 context sentences
    Summary · context
    Bioequivalence was confirmed if 90% confidence intervals for geometric mean ratio between B/A or C/A fell within 80-125% equivalence limits for area under the concentration-time curve (AUC) and maximum concentration (Cmax) in whole blood.
    Summary · context
    A 60 mL oral solution of trofinetide (12 g) was administered in three dosing periods: morning fasted (A; reference), morning fed (B), and evening fasted (C).
    Summary · context
    Healthy adult subjects (18-45 years) were randomized to sequence ABC (n = 19) or BAC (n = 22).
  3. 03HumanNon-randomized trialPharmacokinetics

    In healthy adults, evening fasted trofinetide met AUC bioequivalence criteria versus morning fasted dosing.

    In plain wordsIn healthy adults, trofinetide met total-exposure equivalence criteria after evening versus morning dosing without food.

    Peptide
    Trofinetide
    Outcome
    Not applicableAUC bioequivalence, evening effect
    Study

    n = 41

    Comparator
    Morning fasted dosing
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    12 g (60 mL oral solution) · oralAs given in this study (human).

    Source sentences

    Summary
    Bioequivalence criteria were met for all conditions (i.e., morning fed vs. morning fasted and evening fasted vs. morning fasted) except Cmax in the fed versus fasted condition, which was just below the bioequivalence limit (75.49%), suggesting a negligible food effect and lack of diurnal…
    3 context sentences
    Summary · context
    Bioequivalence was confirmed if 90% confidence intervals for geometric mean ratio between B/A or C/A fell within 80-125% equivalence limits for area under the concentration-time curve (AUC) and maximum concentration (Cmax) in whole blood.
    Summary · context
    A 60 mL oral solution of trofinetide (12 g) was administered in three dosing periods: morning fasted (A; reference), morning fed (B), and evening fasted (C).
    Summary · context
    Healthy adult subjects (18-45 years) were randomized to sequence ABC (n = 19) or BAC (n = 22).
  4. 04HumanNon-randomized trialPharmacokinetics

    In healthy adults, evening fasted trofinetide met Cmax bioequivalence criteria versus morning fasted dosing.

    In plain wordsIn healthy adults, trofinetide met peak-level equivalence criteria after evening versus morning dosing without food.

    Peptide
    Trofinetide
    Outcome
    Not applicableCmax bioequivalence, evening effect
    Study

    n = 41

    Comparator
    Morning fasted dosing
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    12 g (60 mL oral solution) · oralAs given in this study (human).

    Source sentences

    Summary
    Bioequivalence criteria were met for all conditions (i.e., morning fed vs. morning fasted and evening fasted vs. morning fasted) except Cmax in the fed versus fasted condition, which was just below the bioequivalence limit (75.49%), suggesting a negligible food effect and lack of diurnal…
    3 context sentences
    Summary · context
    Bioequivalence was confirmed if 90% confidence intervals for geometric mean ratio between B/A or C/A fell within 80-125% equivalence limits for area under the concentration-time curve (AUC) and maximum concentration (Cmax) in whole blood.
    Summary · context
    A 60 mL oral solution of trofinetide (12 g) was administered in three dosing periods: morning fasted (A; reference), morning fed (B), and evening fasted (C).
    Summary · context
    Healthy adult subjects (18-45 years) were randomized to sequence ABC (n = 19) or BAC (n = 22).
  5. 05HumanNon-randomized trialPharmacokinetics

    In healthy adults, trofinetide was primarily excreted unchanged in urine.

    In plain wordsIn healthy adults, most trofinetide left the body unchanged in urine.

    Peptide
    Trofinetide
    Outcome
    Not applicableUrinary excretion
    Study

    n = 41

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    12 g (60 mL oral solution) · oralAs given in this study (human).

    Source sentences

    Summary
    Trofinetide was primarily excreted unchanged in urine.
    2 context sentences
    Summary · context
    A 60 mL oral solution of trofinetide (12 g) was administered in three dosing periods: morning fasted (A; reference), morning fed (B), and evening fasted (C).
    Summary · context
    Healthy adult subjects (18-45 years) were randomized to sequence ABC (n = 19) or BAC (n = 22).
  6. 06HumanNon-randomized trialSafety outcome

    In healthy adults, oral trofinetide was well tolerated.

    In plain wordsIn healthy adults, oral trofinetide was well tolerated.

    Peptide
    Trofinetide
    Outcome
    Not applicableTolerability
    Study

    n = 41

    Outcome group
    Adverse events · Whole body
    Studied dose
    12 g (60 mL oral solution) · oralAs given in this study (human).

    Source sentences

    Summary
    Trofinetide was well tolerated, and there were no significant changes in vital signs or laboratory parameters.
    2 context sentences
    Summary · context
    A 60 mL oral solution of trofinetide (12 g) was administered in three dosing periods: morning fasted (A; reference), morning fed (B), and evening fasted (C).
    Summary · context
    Healthy adult subjects (18-45 years) were randomized to sequence ABC (n = 19) or BAC (n = 22).
  7. 07HumanNon-randomized trialSafety outcome

    In healthy adults receiving trofinetide, vital signs showed no significant changes.

    In plain wordsIn healthy adults receiving trofinetide, vital signs did not change significantly.

    Peptide
    Trofinetide
    Outcome
    No significant changeVital signs
    Study

    n = 41

    Outcome group
    Adverse events · Whole body
    Studied dose
    12 g (60 mL oral solution) · oralAs given in this study (human).

    Source sentences

    Summary
    Trofinetide was well tolerated, and there were no significant changes in vital signs or laboratory parameters.
    2 context sentences
    Summary · context
    A 60 mL oral solution of trofinetide (12 g) was administered in three dosing periods: morning fasted (A; reference), morning fed (B), and evening fasted (C).
    Summary · context
    Healthy adult subjects (18-45 years) were randomized to sequence ABC (n = 19) or BAC (n = 22).
  8. 08HumanNon-randomized trialSafety outcome

    In healthy adults receiving trofinetide, laboratory parameters showed no significant changes.

    In plain wordsIn healthy adults receiving trofinetide, laboratory test results did not change significantly.

    Peptide
    Trofinetide
    Outcome
    No significant changeLaboratory parameters
    Study

    n = 41

    Outcome group
    Adverse events · Whole body
    Studied dose
    12 g (60 mL oral solution) · oralAs given in this study (human).

    Source sentences

    Summary
    Trofinetide was well tolerated, and there were no significant changes in vital signs or laboratory parameters.
    2 context sentences
    Summary · context
    A 60 mL oral solution of trofinetide (12 g) was administered in three dosing periods: morning fasted (A; reference), morning fed (B), and evening fasted (C).
    Summary · context
    Healthy adult subjects (18-45 years) were randomized to sequence ABC (n = 19) or BAC (n = 22).

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.

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