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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02022254
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.3
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 2; Healthy	Drug: semaglutide; Drug: placebo; Drug: metformin; Drug: warfarin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 17, 2013
• Actual Primary Completion Date: Aug 28, 2014
• Actual Study Completion Date: Aug 28, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Semaglutide administrations

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.

Outcome Measures

Primary Outcome Measures

1. 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)]

2. 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)]

3. 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)]

Secondary Outcome Measures

1. 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)]

2. 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)]

3. 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)]

4. Incremental area under the INR (international normalised ratio) -curve [From 0 to 168 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Berlin		Germany	10117

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02022254
• Other Study ID Numbers: NN9535-3817; 2012-005072-33; U1111-1136-6442
• First Posted: Dec 27, 2013
• Last Update Posted: Apr 4, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin; Warfarin

Study Results

No Results Posted as of Apr 4, 2017