| Trial ID: | L7155 |
| Source ID: | NCT02022254
|
| Associated Drug: |
Semaglutide
|
| Title: |
Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2|Healthy
|
| Interventions: |
DRUG: semaglutide|DRUG: placebo|DRUG: metformin|DRUG: warfarin
|
| Outcome Measures: |
Primary: 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)|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: 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
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: |Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-12-17
|
| Completion Date: |
2014-08-28
|
| Results First Posted: |
|
| Last Update Posted: |
2017-04-04
|
| Locations: |
Novo Nordisk Investigational Site, Berlin, 10117, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02022254
|
