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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
Semaglutide placebo will be administered s.c.
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.
Novo Nordisk Investigational Site
Berlin, Germany
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)
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)
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)
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)
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)
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)
Incremental area under the INR (international normalised ratio) -curve
Time frame: From 0 to 168 hours
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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.