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Study · Randomized controlled trial · n = 71 · 2013

5 results

Plecanatide, an oral guanylate cyclase C agonist acting locally in the gastrointestinal tract, is safe and well-tolerated in single doses.

Shailubhai K, Comiskey S, Foss JA, Feng R, Barrow L, Comer GM, Jacob GS

Digestive diseases and sciences27 Apr 2013Cited by 72 (Europe PMC)

PMID23625291 (opens in a new tab)DOI10.1007/s10620-013-2684-z (opens in a new tab)PepBankPUB-23625291
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 study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In healthy volunteers, TEAE rates were comparable with plecanatide and placebo (24.5% versus 22.2%).

    In plain wordsIn healthy volunteers, adverse event rates were comparable with plecanatide and placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseTreatment-emergent adverse events
    Study

    n = 71

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.1 to 48.6 mg · oral · single doseAs given in this study (human).

    Measurements

    TEAE rate
    24.5%
    plecanatide
    TEAE rate
    22.2%
    placebo

    Source sentences

    Summary
    The number of TEAEs reported by subjects who received plecanatide or placebo was comparable (24.5 vs. 22.2%, respectively).
    1 context sentence
    Summary · context
    A total of 72 healthy volunteers at a single site were randomized in 9 cohorts to receive oral plecanatide or placebo from 0.1 to 48.6 mg.
  2. 02HumanNon-randomized trialSafety outcome

    In healthy volunteers, single-dose plecanatide was safe and well tolerated at all tested doses.

    In plain wordsIn healthy volunteers, single doses of plecanatide were well tolerated.

    Peptide
    Plecanatide
    Outcome
    Not applicableTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.1 to 48.6 mg · oral · single doseAs given in this study (human).

    Source sentences

    Summary
    Plecanatide was safe and well-tolerated at all dose levels.
    1 context sentence
    Summary · context
    A total of 72 healthy volunteers at a single site were randomized in 9 cohorts to receive oral plecanatide or placebo from 0.1 to 48.6 mg.
  3. 03HumanNon-randomized trialSafety outcome

    In healthy volunteers, plecanatide showed no dose-related increase in TEAEs.

    In plain wordsIn healthy volunteers, adverse events did not increase with higher plecanatide doses.

    Peptide
    Plecanatide
    Outcome
    No significant changeDose-related TEAE increase
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.1 to 48.6 mg · oral · single doseAs given in this study (human).

    Source sentences

    Summary
    There were no dose-related increases in TEAEs or any SAEs reported.
    1 context sentence
    Summary · context
    A total of 72 healthy volunteers at a single site were randomized in 9 cohorts to receive oral plecanatide or placebo from 0.1 to 48.6 mg.
  4. 04HumanNon-randomized trialSafety outcome

    In healthy volunteers, no serious adverse events were reported during the plecanatide study.

    In plain wordsIn healthy volunteers, no serious adverse events were reported during the plecanatide study.

    Peptide
    Plecanatide
    Outcome
    Not applicableSerious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.1 to 48.6 mg · oral · single doseAs given in this study (human).

    Source sentences

    Summary
    There were no dose-related increases in TEAEs or any SAEs reported.
    1 context sentence
    Summary · context
    A total of 72 healthy volunteers at a single site were randomized in 9 cohorts to receive oral plecanatide or placebo from 0.1 to 48.6 mg.
  5. 05HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, oral plecanatide had no measurable systemic absorption with an assay sensitive to 1 ng/mL.

    In plain wordsIn healthy volunteers, plecanatide absorption into blood was undetectable with the study assay.

    Peptide
    Plecanatide
    Outcome
    Not applicableSystemic absorption
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.1 to 48.6 mg · oral · single doseAs given in this study (human).

    Measurements

    Assay sensitivity limit
    1 ng/mL
    oral plecanatide; no measurable systemic absorption

    Source sentences

    Summary
    No measurable systemic absorption of oral plecanatide was observed at any of the oral doses studied, utilizing an assay sensitive down to 1 ng/mL.
    1 context sentence
    Summary · context
    A total of 72 healthy volunteers at a single site were randomized in 9 cohorts to receive oral plecanatide or placebo from 0.1 to 48.6 mg.

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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