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Study · Non-randomized trial · 2008

9 results

Pharmacokinetics, safety, and tolerability of teduglutide, a glucagon-like peptide-2 (GLP-2) analog, following multiple ascending subcutaneous administrations in healthy subjects.

Marier JF, Beliveau M, Mouksassi MS, Shaw P, Cyran J, Kesavan J, Wallens J, Zahir H, Wells D, Caminis J

Journal of clinical pharmacology1 Nov 2008Cited by 65 (Europe PMC)

PMID18974283 (opens in a new tab)DOI10.1177/0091270008320605 (opens in a new tab)PepBankPUB-18974283
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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanNon-randomized trialPharmacokinetics

    In healthy subjects, teduglutide systemic exposures were very similar on days 1 and 8, suggesting minimal accumulation.

    In plain wordsIn healthy subjects, teduglutide exposure was similar on days 1 and 8, suggesting little accumulation.

    Peptide
    Teduglutide
    Outcome
    Direction not reportedSystemic exposure accumulation
    Study

    n: not reported in source

    Comparator
    day 1
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · 8 daysAs given in this study (human).

    Source sentences

    Summary
    Mean systemic exposures to teduglutide were very similar on days 1 and 8, suggesting minimal, if any, accumulation following once-daily repeated administrations.
    2 context sentences
    Summary · context
    The pharmacokinetics, safety, and tolerability of teduglutide in healthy subjects (N = 64) were assessed following daily subcutaneous administrations for 8 days in a double-blinded, randomized, placebo-controlled, ascending-dose study.
    Summary · context
    Teduglutide treatments were administered as a 50-mg/mL (10, 15, 20, 25, 30, 50, and 80 mg) or 20-mg/mL (20 mg) formulation.
  2. 02HumanNon-randomized trialPharmacokinetics

    In healthy men, teduglutide apparent clearance remained constant across doses, with a mean of 0.155 L/h/kg.

    In plain wordsIn healthy men, teduglutide clearance stayed constant across doses, averaging 0.155 L/h/kg.

    Peptide
    Teduglutide
    Outcome
    Direction not reportedApparent clearance in men
    Study

    n: not reported in source

    Comparator
    other doses of 50-mg/mL formulation
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10, 15, 20, 25, 30, 50, and 80 mg · subcutaneous · 8 daysAs given in this study (human).

    Measurements

    Apparent clearance
    0.155 L/h/kg
    male subjects

    Source sentences

    Summary
    The apparent clearance of teduglutide following administration of the 50-mg/mL formulation was constant over the dose range, with mean values in male and female subjects of 0.155 and 0.159 L/h/kg, respectively.
    2 context sentences
    Summary · context
    The pharmacokinetics, safety, and tolerability of teduglutide in healthy subjects (N = 64) were assessed following daily subcutaneous administrations for 8 days in a double-blinded, randomized, placebo-controlled, ascending-dose study.
    Summary · context
    Teduglutide treatments were administered as a 50-mg/mL (10, 15, 20, 25, 30, 50, and 80 mg) or 20-mg/mL (20 mg) formulation.
  3. 03HumanNon-randomized trialPharmacokinetics

    In healthy women, teduglutide apparent clearance remained constant across doses, with a mean of 0.159 L/h/kg.

    In plain wordsIn healthy women, teduglutide clearance stayed constant across doses, averaging 0.159 L/h/kg.

    Peptide
    Teduglutide
    Outcome
    Direction not reportedApparent clearance in women
    Study

    n: not reported in source

    Comparator
    other doses of 50-mg/mL formulation
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10, 15, 20, 25, 30, 50, and 80 mg · subcutaneous · 8 daysAs given in this study (human).

    Measurements

    Apparent clearance
    0.159 L/h/kg
    female subjects

    Source sentences

    Summary
    The apparent clearance of teduglutide following administration of the 50-mg/mL formulation was constant over the dose range, with mean values in male and female subjects of 0.155 and 0.159 L/h/kg, respectively.
    2 context sentences
    Summary · context
    The pharmacokinetics, safety, and tolerability of teduglutide in healthy subjects (N = 64) were assessed following daily subcutaneous administrations for 8 days in a double-blinded, randomized, placebo-controlled, ascending-dose study.
    Summary · context
    Teduglutide treatments were administered as a 50-mg/mL (10, 15, 20, 25, 30, 50, and 80 mg) or 20-mg/mL (20 mg) formulation.
  4. 04HumanNon-randomized trialPharmacokinetics

    In healthy subjects, teduglutide 20-mg/mL formulation produced approximately 15% higher peak plasma concentrations than the 50-mg/mL formulation.

    In plain wordsIn healthy subjects, the 20-mg/mL teduglutide formulation produced approximately 15% higher peak concentrations than the 50-mg/mL formulation.

    Peptide
    Teduglutide
    Outcome
    IncreasePeak plasma concentration by formulation
    Study

    n: not reported in source

    Comparator
    50-mg/mL formulation (0.4 mL)
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    20 mg · subcutaneous · 8 daysAs given in this study (human).

    Measurements

    Peak concentration increase
    ≈ 15%
    20-mg/mL versus 50-mg/mL formulation

    Source sentences

    Summary
    Peak plasma concentrations and total exposure of teduglutide after subcutaneous injection of a 20-mg/mL formulation (1.0 mL) were approximately 15% and 78% higher than those observed with the 50-mg/mL formulation (0.4 mL), respectively.
    2 context sentences
    Summary · context
    The pharmacokinetics, safety, and tolerability of teduglutide in healthy subjects (N = 64) were assessed following daily subcutaneous administrations for 8 days in a double-blinded, randomized, placebo-controlled, ascending-dose study.
    Summary · context
    Teduglutide treatments were administered as a 50-mg/mL (10, 15, 20, 25, 30, 50, and 80 mg) or 20-mg/mL (20 mg) formulation.
  5. 05HumanNon-randomized trialPharmacokinetics

    In healthy subjects, teduglutide 20-mg/mL formulation produced approximately 78% higher total exposure than the 50-mg/mL formulation.

    In plain wordsIn healthy subjects, the 20-mg/mL teduglutide formulation produced approximately 78% higher total exposure than the 50-mg/mL formulation.

    Peptide
    Teduglutide
    Outcome
    IncreaseTotal exposure by formulation
    Study

    n: not reported in source

    Comparator
    50-mg/mL formulation (0.4 mL)
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    20 mg · subcutaneous · 8 daysAs given in this study (human).

    Measurements

    Total exposure increase
    ≈ 78%
    20-mg/mL versus 50-mg/mL formulation

    Source sentences

    Summary
    Peak plasma concentrations and total exposure of teduglutide after subcutaneous injection of a 20-mg/mL formulation (1.0 mL) were approximately 15% and 78% higher than those observed with the 50-mg/mL formulation (0.4 mL), respectively.
    2 context sentences
    Summary · context
    The pharmacokinetics, safety, and tolerability of teduglutide in healthy subjects (N = 64) were assessed following daily subcutaneous administrations for 8 days in a double-blinded, randomized, placebo-controlled, ascending-dose study.
    Summary · context
    Teduglutide treatments were administered as a 50-mg/mL (10, 15, 20, 25, 30, 50, and 80 mg) or 20-mg/mL (20 mg) formulation.
  6. 06HumanNon-randomized trialSafety outcome

    In healthy subjects, teduglutide treatments were safe and well tolerated.

    In plain wordsIn healthy subjects, teduglutide treatments were safe and well tolerated.

    Peptide
    Teduglutide
    Outcome
    Not applicableTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous · 8 daysAs given in this study (human).

    Source sentences

    Summary
    Teduglutide treatments were safe and well tolerated.
    2 context sentences
    Summary · context
    The pharmacokinetics, safety, and tolerability of teduglutide in healthy subjects (N = 64) were assessed following daily subcutaneous administrations for 8 days in a double-blinded, randomized, placebo-controlled, ascending-dose study.
    Summary · context
    Teduglutide treatments were administered as a 50-mg/mL (10, 15, 20, 25, 30, 50, and 80 mg) or 20-mg/mL (20 mg) formulation.
  7. 07HumanNon-randomized trialSafety outcome

    In the healthy-subject teduglutide study, all but 1 adverse event was mild or moderate.

    In plain wordsIn the healthy-subject teduglutide study, all but 1 adverse event was mild or moderate.

    Peptide
    Teduglutide
    Outcome
    Not applicableAdverse event severity
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous · 8 daysAs given in this study (human).

    Source sentences

    Summary
    All but 1 adverse event was assessed as mild or moderate in severity.
    2 context sentences
    Summary · context
    The pharmacokinetics, safety, and tolerability of teduglutide in healthy subjects (N = 64) were assessed following daily subcutaneous administrations for 8 days in a double-blinded, randomized, placebo-controlled, ascending-dose study.
    Summary · context
    Teduglutide treatments were administered as a 50-mg/mL (10, 15, 20, 25, 30, 50, and 80 mg) or 20-mg/mL (20 mg) formulation.
  8. 08HumanNon-randomized trialSafety outcome

    In healthy subjects, adverse event frequency showed no relationship with teduglutide treatment, except injection site pain.

    In plain wordsIn healthy subjects, adverse event frequency showed no relationship with teduglutide treatment, except injection site pain.

    Peptide
    Teduglutide
    Outcome
    No significant changeAdverse event frequency
    Study

    n: not reported in source

    Comparator
    other teduglutide treatments
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous · 8 daysAs given in this study (human).

    Source sentences

    Summary
    No relationship between teduglutide treatments and frequency of adverse events was observed, with the exception of injection site pain, which increased as a function of dose and injected volume.
    2 context sentences
    Summary · context
    The pharmacokinetics, safety, and tolerability of teduglutide in healthy subjects (N = 64) were assessed following daily subcutaneous administrations for 8 days in a double-blinded, randomized, placebo-controlled, ascending-dose study.
    Summary · context
    Teduglutide treatments were administered as a 50-mg/mL (10, 15, 20, 25, 30, 50, and 80 mg) or 20-mg/mL (20 mg) formulation.
  9. 09HumanObservational studySafety outcome

    In healthy subjects, injection site pain was linked to higher teduglutide doses and injected volumes.

    In plain wordsIn healthy subjects, injection site pain was linked to higher teduglutide doses and injected volumes.

    Peptide
    Teduglutide
    Outcome
    IncreaseInjection site pain
    Study

    n: not reported in source

    Comparator
    lower dose and injected volume
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    Dose not stated · subcutaneous · 8 daysAs given in this study (human).

    Source sentences

    Summary
    No relationship between teduglutide treatments and frequency of adverse events was observed, with the exception of injection site pain, which increased as a function of dose and injected volume.
    2 context sentences
    Summary · context
    The pharmacokinetics, safety, and tolerability of teduglutide in healthy subjects (N = 64) were assessed following daily subcutaneous administrations for 8 days in a double-blinded, randomized, placebo-controlled, ascending-dose study.
    Summary · context
    Teduglutide treatments were administered as a 50-mg/mL (10, 15, 20, 25, 30, 50, and 80 mg) or 20-mg/mL (20 mg) formulation.

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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