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Trial · Interventional

CompletedPhase 1Registry data

Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects

NCTNCT02022254 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3817Other id2012-005072-33Other idU1111-1136-6442
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
24 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Open label (no masking)
Countries
1 country

Germany

Start
17 Dec 2013
Primary completion
28 Aug 2014
Completion
28 Aug 2014
First posted
27 Dec 2013 (estimated)
Last update posted
4 Apr 2017
Conditions
Diabetes · Diabetes Mellitus, Type 2 · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 1

    Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects

    NCT02022254

    17 Dec 2013 to 28 Aug 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted in Europe and Asia. The aim of the trial is to investigate the influence of semaglutide on pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of warfarin and pharmacokinetics of metformin in healthy subjects.

Interventions

  • semaglutideDrug
  • placeboDrug
  • metforminDrug
  • warfarinDrug

Arms1

  • Experimental

    Semaglutide administrations

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Area under the metformin plasma concentration-time curve

    Time frame · During a dosing interval (0-12 hours) after the last of 7 repeated doses of metformin without semaglutide exposure (Day 4) and at semaglutide steady state (Day 104)

  2. Area under the S-warfarin plasma concentration-time curve

    Time frame · From time 0 to 168 hours after a single dose of warfarin without semaglutide exposure (Day 11) and at semaglutide steady state (Day 111)

  3. Area under the R-warfarin plasma concentration-time curve

    Time frame · From time 0 to 168 hours after a single dose of warfarin without semaglutide exposure (Day 11) and at semaglutide steady state (Day 111)

Secondary outcomes(4)

  1. Maximum observed metformin plasma concentration at steady state

    Time frame · From dosing until 30 hours after the last of 7 repeated doses without semaglutide exposure and at semaglutide steady state (metformin administration on Days 4 and 104)

  2. Maximum observed S-warfarin plasma concentration after single dose

    Time frame · (0-168 hours) after a single dose of warfarin without semaglutide exposure and at semaglutide steady state (warfarin administrations on Days 11 and 111)

  3. Maximum observed R-warfarin plasma concentration after single dose

    Time frame · (0-168 hours) after a single dose of warfarin without semaglutide exposure and at semaglutide steady state (warfarin administrations on Days 11 and 110)

  4. Incremental area under the INR (international normalised ratio) -curve

    Time frame · From 0 to 168 hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2017

7 results

Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects.

Hausner et al. 2017Clinical pharmacokineticscited by 51

PMID 28349387PMC5648738DOI 10.1007/s40262-017-0532-6PUB-28349387

Free to read · publisher termsCC BY-NC7 results
Read at sourceSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male and female, age between 18 and 55 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 23 and 30 kg/m\^2 (both inclusive) Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearingpotential and not using adequate contraceptive methods for the duration of the trial and for 5 weeks following the last dose of semaglutide. Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner * Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases * Use of prescription or non-prescription systemic or topical medicinal products (including routine or non-routine vitamins or herbal products, but excluding paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2 * Smoking, drug or alcohol abuse

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