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Study · Observational study · n = 61 · 2017

10 results

Population pharmacokinetics of NNZ-2566 in healthy subjects.

Oosterholt SP, Horrigan J, Jones N, Glass L, Della Pasqua O

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences15 May 2017Cited by 12 (Europe PMC)

PMID28522374 (opens in a new tab)DOI10.1016/j.ejps.2017.05.032 (opens in a new tab)PepBankPUB-28522374
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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. 01HumanObservational studyPharmacokinetics

    In healthy subjects given NNZ-2566, a two-compartment model with first-order absorption and elimination best described pharmacokinetics.

    In plain wordsIn healthy people given NNZ-2566, a two-compartment model best described how the drug entered and left the body.

    Peptide
    Trofinetide
    Outcome
    Not applicablePharmacokinetic model
    Study

    n = 61

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    6.0-100 mg/kg orally and 0.1-30 mg/kg intravenously · oral and intravenousAs given in this study (human).

    Source sentences

    Summary
    A two-compartment model with first order absorption and elimination was found to best describe the pharmacokinetics of NNZ-2566.
    3 context sentences
    Summary · context
    In the current study we characterise the population pharmacokinetics of NNZ-2566 after administration of single and repeated ascending doses to healthy subjects.
    Summary · context
    A meta-analytical approach was used to analyse pharmacokinetic data from 3 different studies, in which a total of 61 healthy subjects (median age: 23years, range: 19 to 38) were treated with NNZ-2566.
    Summary · context
    Doses of NNZ-2566 ranged from 6.0 to 100mg/kg after oral administration and from 0.1 to 30mg/kg after intravenous administration.
  2. 02HumanObservational studyPharmacokinetics

    In healthy subjects given NNZ-2566, clearance, absorption rate, central and peripheral distribution volumes, and inter-compartmental clearance varied between individuals.

    In plain wordsIn healthy people given NNZ-2566, drug clearance, absorption rate, distribution volumes, and transfer between compartments varied between people.

    Peptide
    Trofinetide
    Outcome
    Not applicableInter-individual pharmacokinetic variability
    Study

    n = 61

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    6.0-100 mg/kg orally and 0.1-30 mg/kg intravenously · oral and intravenousAs given in this study (human).

    Source sentences

    Summary
    Inter-individual variability was identified in clearance, absorption rate, central volume of distribution, peripheral volume of distribution and inter-compartmental clearance.
    3 context sentences
    Summary · context
    In the current study we characterise the population pharmacokinetics of NNZ-2566 after administration of single and repeated ascending doses to healthy subjects.
    Summary · context
    A meta-analytical approach was used to analyse pharmacokinetic data from 3 different studies, in which a total of 61 healthy subjects (median age: 23years, range: 19 to 38) were treated with NNZ-2566.
    Summary · context
    Doses of NNZ-2566 ranged from 6.0 to 100mg/kg after oral administration and from 0.1 to 30mg/kg after intravenous administration.
  3. 03HumanObservational studyPharmacokinetics

    In healthy subjects given NNZ-2566, population predicted clearance was 10.35 L/h.

    In plain wordsIn healthy people given NNZ-2566, the model estimated drug clearance at 10.35 L/h.

    Peptide
    Trofinetide
    Outcome
    Not applicablePopulation predicted clearance
    Study

    n = 61

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    6.0-100 mg/kg orally and 0.1-30 mg/kg intravenously · oral and intravenousAs given in this study (human).

    Measurements

    Population predicted clearance
    10.35 L/h
    healthy subjects

    Source sentences

    Summary
    Population predicted clearance and central volume of distribution were 10.35L/h and 20.23L, respectively.
    3 context sentences
    Summary · context
    In the current study we characterise the population pharmacokinetics of NNZ-2566 after administration of single and repeated ascending doses to healthy subjects.
    Summary · context
    A meta-analytical approach was used to analyse pharmacokinetic data from 3 different studies, in which a total of 61 healthy subjects (median age: 23years, range: 19 to 38) were treated with NNZ-2566.
    Summary · context
    Doses of NNZ-2566 ranged from 6.0 to 100mg/kg after oral administration and from 0.1 to 30mg/kg after intravenous administration.
  4. 04HumanObservational studyPharmacokinetics

    In healthy subjects given NNZ-2566, population predicted central volume of distribution was 20.23 L.

    In plain wordsIn healthy people given NNZ-2566, the model estimated central distribution volume at 20.23 L.

    Peptide
    Trofinetide
    Outcome
    Not applicablePopulation predicted central volume of distribution
    Study

    n = 61

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    6.0-100 mg/kg orally and 0.1-30 mg/kg intravenously · oral and intravenousAs given in this study (human).

    Measurements

    Population predicted central volume of distribution
    20.23 L
    healthy subjects

    Source sentences

    Summary
    Population predicted clearance and central volume of distribution were 10.35L/h and 20.23L, respectively.
    3 context sentences
    Summary · context
    In the current study we characterise the population pharmacokinetics of NNZ-2566 after administration of single and repeated ascending doses to healthy subjects.
    Summary · context
    A meta-analytical approach was used to analyse pharmacokinetic data from 3 different studies, in which a total of 61 healthy subjects (median age: 23years, range: 19 to 38) were treated with NNZ-2566.
    Summary · context
    Doses of NNZ-2566 ranged from 6.0 to 100mg/kg after oral administration and from 0.1 to 30mg/kg after intravenous administration.
  5. 05HumanObservational studyPharmacokinetics

    In healthy subjects, NNZ-2566 showed dose proportionality across the evaluated dose range.

    In plain wordsIn healthy people, NNZ-2566 exposure changed in proportion to dose across the tested range.

    Peptide
    Trofinetide
    Outcome
    Not applicableDose proportionality
    Study

    n = 61

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    6.0-100 mg/kg orally and 0.1-30 mg/kg intravenously · oral and intravenousAs given in this study (human).

    Source sentences

    Summary
    Dose proportionality was observed across the dose range evaluated in healthy subjects.
    3 context sentences
    Summary · context
    In the current study we characterise the population pharmacokinetics of NNZ-2566 after administration of single and repeated ascending doses to healthy subjects.
    Summary · context
    A meta-analytical approach was used to analyse pharmacokinetic data from 3 different studies, in which a total of 61 healthy subjects (median age: 23years, range: 19 to 38) were treated with NNZ-2566.
    Summary · context
    Doses of NNZ-2566 ranged from 6.0 to 100mg/kg after oral administration and from 0.1 to 30mg/kg after intravenous administration.
  6. 06HumanObservational studyPharmacokinetics

    In healthy subjects receiving NNZ-2566, no accumulation was observed during treatment.

    In plain wordsIn healthy people receiving NNZ-2566, the drug did not accumulate during treatment.

    Peptide
    Trofinetide
    Outcome
    No significant changeAccumulation
    Study

    n = 61

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    6.0-100 mg/kg orally and 0.1-30 mg/kg intravenously · oral and intravenousAs given in this study (human).

    Source sentences

    Summary
    No accumulation, metabolic inhibition or induction was observed during the course of treatment.
    3 context sentences
    Summary · context
    In the current study we characterise the population pharmacokinetics of NNZ-2566 after administration of single and repeated ascending doses to healthy subjects.
    Summary · context
    A meta-analytical approach was used to analyse pharmacokinetic data from 3 different studies, in which a total of 61 healthy subjects (median age: 23years, range: 19 to 38) were treated with NNZ-2566.
    Summary · context
    Doses of NNZ-2566 ranged from 6.0 to 100mg/kg after oral administration and from 0.1 to 30mg/kg after intravenous administration.
  7. 07HumanObservational studyPharmacokinetics

    In healthy subjects receiving NNZ-2566, no metabolic inhibition was observed during treatment.

    In plain wordsIn healthy people receiving NNZ-2566, the study found no metabolic inhibition during treatment.

    Peptide
    Trofinetide
    Outcome
    No significant changeMetabolic inhibition
    Study

    n = 61

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    6.0-100 mg/kg orally and 0.1-30 mg/kg intravenously · oral and intravenousAs given in this study (human).

    Source sentences

    Summary
    No accumulation, metabolic inhibition or induction was observed during the course of treatment.
    3 context sentences
    Summary · context
    In the current study we characterise the population pharmacokinetics of NNZ-2566 after administration of single and repeated ascending doses to healthy subjects.
    Summary · context
    A meta-analytical approach was used to analyse pharmacokinetic data from 3 different studies, in which a total of 61 healthy subjects (median age: 23years, range: 19 to 38) were treated with NNZ-2566.
    Summary · context
    Doses of NNZ-2566 ranged from 6.0 to 100mg/kg after oral administration and from 0.1 to 30mg/kg after intravenous administration.
  8. 08HumanObservational studyPharmacokinetics

    In healthy subjects receiving NNZ-2566, no metabolic induction was observed during treatment.

    In plain wordsIn healthy people receiving NNZ-2566, the study found no metabolic induction during treatment.

    Peptide
    Trofinetide
    Outcome
    No significant changeMetabolic induction
    Study

    n = 61

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    6.0-100 mg/kg orally and 0.1-30 mg/kg intravenously · oral and intravenousAs given in this study (human).

    Source sentences

    Summary
    No accumulation, metabolic inhibition or induction was observed during the course of treatment.
    3 context sentences
    Summary · context
    In the current study we characterise the population pharmacokinetics of NNZ-2566 after administration of single and repeated ascending doses to healthy subjects.
    Summary · context
    A meta-analytical approach was used to analyse pharmacokinetic data from 3 different studies, in which a total of 61 healthy subjects (median age: 23years, range: 19 to 38) were treated with NNZ-2566.
    Summary · context
    Doses of NNZ-2566 ranged from 6.0 to 100mg/kg after oral administration and from 0.1 to 30mg/kg after intravenous administration.
  9. 09HumanObservational studyPharmacokinetics

    In healthy subjects given NNZ-2566, the reported half-life was 1.4 h.

    In plain wordsIn healthy people given NNZ-2566, the reported drug half-life was 1.4 h.

    Peptide
    Trofinetide
    Outcome
    Not applicableHalf-life
    Study

    n = 61

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    6.0-100 mg/kg orally and 0.1-30 mg/kg intravenously · oral and intravenousAs given in this study (human).

    Measurements

    Half-life
    1.4 h
    healthy subjects

    Source sentences

    Summary
    The relatively short half-life of 1.4h
    3 context sentences
    Summary · context
    In the current study we characterise the population pharmacokinetics of NNZ-2566 after administration of single and repeated ascending doses to healthy subjects.
    Summary · context
    A meta-analytical approach was used to analyse pharmacokinetic data from 3 different studies, in which a total of 61 healthy subjects (median age: 23years, range: 19 to 38) were treated with NNZ-2566.
    Summary · context
    Doses of NNZ-2566 ranged from 6.0 to 100mg/kg after oral administration and from 0.1 to 30mg/kg after intravenous administration.
  10. 10HumanObservational studyPharmacokinetics

    In healthy subjects, oral NNZ-2566 bioavailability appeared to vary with food intake.

    In plain wordsIn healthy people, food intake appeared linked to variation in oral NNZ-2566 bioavailability.

    Peptide
    Trofinetide
    Outcome
    Direction not reportedFood-associated oral bioavailability variation
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    6.0-100 mg/kg · oralAs given in this study (human).

    Source sentences

    Summary
    In addition, oral bioavailability appeared to vary with food intake.
    3 context sentences
    Summary · context
    In the current study we characterise the population pharmacokinetics of NNZ-2566 after administration of single and repeated ascending doses to healthy subjects.
    Summary · context
    A meta-analytical approach was used to analyse pharmacokinetic data from 3 different studies, in which a total of 61 healthy subjects (median age: 23years, range: 19 to 38) were treated with NNZ-2566.
    Summary · context
    Doses of NNZ-2566 ranged from 6.0 to 100mg/kg after oral administration and from 0.1 to 30mg/kg after intravenous administration.

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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

    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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