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Study · Non-randomized trial · n = 21 · 2005

6 results

Effect of exenatide on the steady-state pharmacokinetics of digoxin.

Kothare PA, Soon DK, Linnebjerg H, Park S, Chan C, Yeo A, Lim M, Mace KF, Wise SD

Journal of clinical pharmacology1 Sept 2005Cited by 48 (Europe PMC)

PMID16100297 (opens in a new tab)DOI10.1177/0091270005278806 (opens in a new tab)PepBankPUB-16100297
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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanNon-randomized trialPharmacokinetics

    In healthy men, exenatide coadministration did not alter overall steady-state digoxin exposure.

    In plain wordsIn healthy men, adding exenatide did not change total digoxin exposure compared with digoxin alone.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeDigoxin steady-state AUC
    Study

    n = 21

    Comparator
    Digoxin without exenatide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 microg twice daily · days 8-12As given in this study (human).

    Source sentences

    Summary
    Exenatide coadministration did not change the overall 24-hour steady-state digoxin exposure (AUCtau,ss) and Cmin,ss but caused a 17% decrease in mean plasma digoxin Cmax,ss (1.40 to 1.16 ng/mL) and an increase in digoxin tmax,ss (median increase, 2.5 hours).
    3 context sentences
    Summary · context
    This open-label study investigated the effect of exenatide coadministration on the steady-state plasma pharmacokinetics of digoxin.
    Summary · context
    A total of 21 healthy male subjects received digoxin (day 1, 0.5 mg twice daily; days 2-12, 0.25 mg once daily) and exenatide (days 8-12, 10 microg twice daily).
    Summary · context
    Digoxin plasma and urine concentrations were measured on days 7 and 12.
  2. 02HumanNon-randomized trialPharmacokinetics

    In healthy men, exenatide coadministration did not alter steady-state minimum digoxin concentration.

    In plain wordsIn healthy men, adding exenatide did not change minimum digoxin levels compared with digoxin alone.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeDigoxin minimum concentration
    Study

    n = 21

    Comparator
    Digoxin without exenatide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 microg twice daily · days 8-12As given in this study (human).

    Source sentences

    Summary
    Exenatide coadministration did not change the overall 24-hour steady-state digoxin exposure (AUCtau,ss) and Cmin,ss but caused a 17% decrease in mean plasma digoxin Cmax,ss (1.40 to 1.16 ng/mL) and an increase in digoxin tmax,ss (median increase, 2.5 hours).
    3 context sentences
    Summary · context
    This open-label study investigated the effect of exenatide coadministration on the steady-state plasma pharmacokinetics of digoxin.
    Summary · context
    A total of 21 healthy male subjects received digoxin (day 1, 0.5 mg twice daily; days 2-12, 0.25 mg once daily) and exenatide (days 8-12, 10 microg twice daily).
    Summary · context
    Digoxin plasma and urine concentrations were measured on days 7 and 12.
  3. 03HumanNon-randomized trialPharmacokinetics

    In healthy men, exenatide coadministration reduced mean steady-state digoxin Cmax by 17% (1.40 to 1.16 ng/mL); the decrease was statistically significant and peak concentrations stayed within the therapeutic range in all subjects.

    In plain wordsIn healthy men, adding exenatide lowered peak digoxin levels by 17%, and peaks stayed within the therapeutic range.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseDigoxin peak concentration
    Study

    n = 21

    Comparator
    Digoxin without exenatide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 microg twice daily · days 8-12As given in this study (human).

    Measurements

    Mean plasma digoxin Cmax,ss
    1.4 ng/mL
    digoxin before exenatide
    Mean plasma digoxin Cmax,ss
    1.16 ng/mL
    digoxin with exenatide
    Decrease in digoxin Cmax,ss
    17%
    with exenatide

    Source sentences

    Summary
    caused a 17% decrease in mean plasma digoxin Cmax,ss (1.40 to 1.16 ng/mL)
    Summary
    Although the decrease in digoxin Cmax,ss was statistically significant, peak concentrations were within the therapeutic concentration range in all subjects.
    2 context sentences
    Summary · context
    This open-label study investigated the effect of exenatide coadministration on the steady-state plasma pharmacokinetics of digoxin.
    Summary · context
    A total of 21 healthy male subjects received digoxin (day 1, 0.5 mg twice daily; days 2-12, 0.25 mg once daily) and exenatide (days 8-12, 10 microg twice daily).
  4. 04HumanNon-randomized trialPharmacokinetics

    In healthy men, exenatide increased median digoxin time to peak concentration by 2.5 hours.

    In plain wordsIn healthy men, adding exenatide delayed peak digoxin levels compared with digoxin alone.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseDigoxin time to peak concentration
    Study

    n = 21

    Comparator
    Digoxin without exenatide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 microg twice daily · days 8-12As given in this study (human).

    Measurements

    Median increase in digoxin tmax,ss
    2.5 hours
    with exenatide

    Source sentences

    Summary
    Exenatide coadministration did not change the overall 24-hour steady-state digoxin exposure (AUCtau,ss) and Cmin,ss but caused a 17% decrease in mean plasma digoxin Cmax,ss (1.40 to 1.16 ng/mL) and an increase in digoxin tmax,ss (median increase, 2.5 hours).
    3 context sentences
    Summary · context
    This open-label study investigated the effect of exenatide coadministration on the steady-state plasma pharmacokinetics of digoxin.
    Summary · context
    A total of 21 healthy male subjects received digoxin (day 1, 0.5 mg twice daily; days 2-12, 0.25 mg once daily) and exenatide (days 8-12, 10 microg twice daily).
    Summary · context
    Digoxin plasma and urine concentrations were measured on days 7 and 12.
  5. 05HumanNon-randomized trialPharmacokinetics

    In healthy men, exenatide did not alter urinary digoxin pharmacokinetic parameters.

    In plain wordsIn healthy men, adding exenatide did not change urinary digoxin measures compared with digoxin alone.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeUrinary digoxin pharmacokinetics
    Study

    n = 21

    Comparator
    Digoxin without exenatide
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 microg twice daily · days 8-12As given in this study (human).

    Source sentences

    Summary
    Digoxin urinary pharmacokinetic parameters were not altered.
    3 context sentences
    Summary · context
    This open-label study investigated the effect of exenatide coadministration on the steady-state plasma pharmacokinetics of digoxin.
    Summary · context
    A total of 21 healthy male subjects received digoxin (day 1, 0.5 mg twice daily; days 2-12, 0.25 mg once daily) and exenatide (days 8-12, 10 microg twice daily).
    Summary · context
    Digoxin plasma and urine concentrations were measured on days 7 and 12.
  6. 06HumanNon-randomized trialSafety outcome

    In healthy men, gastrointestinal symptoms were the most common exenatide adverse effects and decreased over time.

    In plain wordsIn healthy men receiving exenatide, digestive symptoms were the most common adverse effects and became less frequent over time.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseGastrointestinal symptoms over time
    Study

    n = 21

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    10 microg twice daily · days 8-12As given in this study (human).

    Source sentences

    Summary
    Gastrointestinal symptoms, the most common adverse effects of exenatide, decreased over time.
    3 context sentences
    Summary · context
    This open-label study investigated the effect of exenatide coadministration on the steady-state plasma pharmacokinetics of digoxin.
    Summary · context
    A total of 21 healthy male subjects received digoxin (day 1, 0.5 mg twice daily; days 2-12, 0.25 mg once daily) and exenatide (days 8-12, 10 microg twice daily).
    Summary · context
    Digoxin plasma and urine concentrations were measured on days 7 and 12.

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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

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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