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

Sponsor
Novo Nordisk A/S
Study ID
NCT02022254
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    Subjects will initiate treatment with 0.25 mg for the first four weeks followed by dose doubling every four weeks up to a dose of 1.0 mg.
  • placebo — DRUG
    Semaglutide placebo will be administered s.c.
  • metformin — DRUG
    For oral administration twice daily, in two periods, each of 3.5 days duration. The first period is initiated before semaglutide treatment and the second period is initiated at the end of semaglutide treatment.
  • warfarin — DRUG
    For oral administration, given as a single dose. The first dose is given before semaglutide treatment and the second dose is given at the end of semaglutide treatment.

Study Details

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.

Key Dates

Start date
Dec 17, 2013
Status verified
Mar 2017
Primary completion
Aug 28, 2014
Completion
Aug 28, 2014

Study Design

Enrollment
24 participants (actual)
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide administrations

Primary Outcome Measure

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) ]

Related Studies