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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Diabetes Mellitus, Type 2 Healthy
Intervention	Drug: semaglutide Drug: placebo Drug: metformin Drug: warfarin
Phase	Phase 1
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT02022254
First Received	December 16, 2013
Last Updated	March 31, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	December 16, 2013
Last Updated Date	March 31, 2014
Start Date	December 2013
Estimated Primary Completion Date	August 2014
Current Primary Outcome Measures	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)] [Designated as safety issue: No] 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)] [Designated as safety issue: No] 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)] [Designated as safety issue: No]
Current Secondary Outcome Measures	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)] [Designated as safety issue: No] 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)] [Designated as safety issue: No] 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)] [Designated as safety issue: No] Incremental area under the INR (international normalised ratio) -curve [Time Frame: From 0 to 168 hours] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects
Official Title	An Open-label, One-sequence Cross Over, Single Centre Trial, Investigating the Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Diabetes Mellitus, Type 2 Healthy
Intervention	Drug: semaglutide 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. Drug: placebo Semaglutide placebo will be administered s.c. Drug: metformin 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. Drug: warfarin 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 Arm (s)	Experimental: Semaglutide administrations

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	17
Estimated Completion Date	August 2014
Estimated Primary Completion Date	August 2014
Eligibility Criteria	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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Germany

Administrative Information[ + expand ][ + ]

NCT Number	NCT02022254
Other Study ID Numbers	NN9535-3817
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Verification Date	March 2014

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