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

Phase 1

Completed

Interventions: Drug: semaglutide
Drug: placebo
Drug: metformin
Drug: warfarin

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Semaglutide administrations	placebo	-
Semaglutide administrations	semaglutide	-
Semaglutide administrations	metformin	-
Semaglutide administrations	warfarin	-

Primary Outcome Measures

Name	Time	Method
Area under the R-warfarin plasma concentration-time curve	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 metformin plasma concentration-time curve	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	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 Outcome Measures

Name	Time	Method
Maximum observed metformin plasma concentration at steady state	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	(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	(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	From 0 to 168 hours

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