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Study · Non-randomized trial · 2021

13 results

Single- and Multiple-Dose Pharmacokinetics and Pharmacodynamics of PN-943, a Gastrointestinal-Restricted Oral Peptide Antagonist of α4β7, in Healthy Volunteers.

Modi NB, Cheng X, Mattheakis L, Hwang CC, Nawabi R, Liu D, Gupta S

Clinical pharmacology in drug development4 May 2021Cited by 14 (Europe PMC)

PMID33942566 (opens in a new tab)PMCIDPMC8597174 (opens in a new tab)DOI10.1002/cpdd.946 (opens in a new tab)PepBankPUB-33942566
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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-ND. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In healthy volunteers, no subjects discontinued PN‑943 because of treatment-emergent adverse events.

    In plain wordsIn healthy volunteers, nobody stopped PN‑943 because of treatment-emergent side effects.

    Peptide
    PN-943
    Outcome
    Not applicableDiscontinuation due to adverse events
    Study

    n: not reported in source

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

    Source sentences

    Summary
    No subjects discontinued due to treatment-emergent adverse events.
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.
  2. 02HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, PN‑943 systemic exposure was minimal.

    In plain wordsIn healthy volunteers, little PN‑943 reached the general circulation.

    Peptide
    PN-943
    Outcome
    Not applicableSystemic exposure
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    Consistent with the gastrointestinal-restricted nature of the peptide, systemic exposure was minimal; there was an approximate dose-proportional increase in area under the plasma concentration-time curve.
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.
  3. 03HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, PN‑943 plasma area under the concentration-time curve increased approximately proportionally with dose.

    In plain wordsIn healthy volunteers, PN‑943 blood exposure increased approximately in proportion to dose.

    Peptide
    PN-943
    Outcome
    IncreaseDose proportionality of plasma AUC
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    Consistent with the gastrointestinal-restricted nature of the peptide, systemic exposure was minimal; there was an approximate dose-proportional increase in area under the plasma concentration-time curve.
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.
  4. 04HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, PN‑943 showed minimal accumulation with once-daily dosing.

    In plain wordsIn healthy volunteers, little PN‑943 accumulated with daily dosing.

    Peptide
    PN-943
    Outcome
    Not applicableAccumulation with once-daily dosing
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    There was minimal accumulation with once-daily dosing and an absence of time-dependent changes in pharmacokinetics.
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.
  5. 05HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, PN‑943 showed no time-dependent pharmacokinetic changes.

    In plain wordsIn healthy volunteers, PN‑943 drug handling did not change with time.

    Peptide
    PN-943
    Outcome
    No significant changeTime-dependent pharmacokinetic changes
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    There was minimal accumulation with once-daily dosing and an absence of time-dependent changes in pharmacokinetics.
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.
  6. 06HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, administration after a high-fat meal reduced PN‑943 peak plasma concentration.

    In plain wordsIn healthy volunteers, a high-fat meal reduced the peak PN‑943 blood concentration.

    Peptide
    PN-943
    Outcome
    DecreasePeak plasma concentration after high-fat meal
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    Administration of PN-943 after a high-fat meal reduced peak plasma concentration and area under the plasma concentration-time curve.
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.
  7. 07HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, administration after a high-fat meal reduced PN‑943 plasma area under the concentration-time curve.

    In plain wordsIn healthy volunteers, a high-fat meal reduced PN‑943 blood exposure.

    Peptide
    PN-943
    Outcome
    DecreasePlasma AUC after high-fat meal
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    Administration of PN-943 after a high-fat meal reduced peak plasma concentration and area under the plasma concentration-time curve.
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.
  8. 08HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, urinary excretion of intact PN‑943 was minimal, below 0.1%.

    In plain wordsIn healthy volunteers, less than 0.1% of intact PN‑943 appeared in urine.

    Peptide
    PN-943
    Outcome
    Not applicableUrinary excretion of intact drug
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Measurements

    Urinary excretion
    < 0.1%
    intact drug

    Source sentences

    Summary
    There was minimal (<0.1%) urinary excretion of intact drug, and there was a dose-related increase in fecal excretion of intact PN-943.
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.
  9. 09HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, fecal excretion of intact PN‑943 increased with dose.

    In plain wordsIn healthy volunteers, more intact PN‑943 appeared in stool as the dose increased.

    Peptide
    PN-943
    Outcome
    IncreaseFecal excretion of intact drug
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    There was minimal (<0.1%) urinary excretion of intact drug, and there was a dose-related increase in fecal excretion of intact PN-943.
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.
  10. 10HumanNon-randomized trialMechanism

    In healthy volunteers, PN‑943 increased blood receptor occupancy with dose.

    In plain wordsIn healthy volunteers, PN‑943 occupied more blood receptors as the dose increased.

    Peptide
    PN-943
    Outcome
    IncreaseBlood receptor occupancy
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    Dose-dependent increases in blood receptor occupancy and reduction in blood receptor expression were observed, supporting target engagement.
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.
  11. 11HumanNon-randomized trialMechanism

    In healthy volunteers, PN‑943 reduced blood receptor expression with dose.

    In plain wordsIn healthy volunteers, PN‑943 reduced blood receptor expression as the dose increased.

    Peptide
    PN-943
    Outcome
    DecreaseBlood receptor expression
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    Dose-dependent increases in blood receptor occupancy and reduction in blood receptor expression were observed, supporting target engagement.
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.
  12. 12HumanNon-randomized trialMechanism

    In healthy volunteers, twice-daily PN‑943 sustained receptor occupancy.

    In plain wordsIn healthy volunteers, twice-daily PN‑943 maintained receptor occupancy.

    Peptide
    PN-943
    Outcome
    Not applicableSustained receptor occupancy with twice-daily dosing
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Source sentences

    Summary
    Twice-daily dosing resulted in sustained receptor occupancy with low plasma fluctuations (143%).
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.
  13. 13HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, twice-daily PN‑943 produced low plasma fluctuations of 143%.

    In plain wordsIn healthy volunteers, twice-daily PN‑943 produced blood-level fluctuations reported as low, at 143%.

    Peptide
    PN-943
    Outcome
    Not applicablePlasma fluctuations with twice-daily dosing
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · oralAs given in this study (human).

    Measurements

    Plasma fluctuations
    143%
    twice-daily dosing

    Source sentences

    Summary
    Twice-daily dosing resulted in sustained receptor occupancy with low plasma fluctuations (143%).
    1 context sentence
    Summary · context
    Two pharmacokinetic/pharmacodynamic studies were conducted in healthy volunteers.

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

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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