A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects
Phase 1
Completed
- Conditions
- HealthyDiabetes
- Interventions
- Registration Number
- NCT02070510
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the influence of oral semaglutide (NNC0113-0217) on the pharmacokinetics of lisinopril and warfarin in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
- Male or female aged 18-75 years (both inclusive) at time of signing informed consent
- Body mass index 20.0-29.9 kg/m^2 (both inclusive)
- A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
Exclusion Criteria
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)
- History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- Hypertension (defined as sitting systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg). If white-coat hypertension is suspected at the screening visit, a repeated measurement is allowed
- Any blood draw in excess of 50 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Victim and perpetrator compounds placebo Subjects receive two different victim compounds (lisinopril and warfarin) and two different perpetrator compounds (placebo semaglutide with carrier and oral semaglutide). Each dosing occasion is separated by a 7-day wash-out period. Victim and perpetrator compounds lisinopril Subjects receive two different victim compounds (lisinopril and warfarin) and two different perpetrator compounds (placebo semaglutide with carrier and oral semaglutide). Each dosing occasion is separated by a 7-day wash-out period. Victim and perpetrator compounds semaglutide Subjects receive two different victim compounds (lisinopril and warfarin) and two different perpetrator compounds (placebo semaglutide with carrier and oral semaglutide). Each dosing occasion is separated by a 7-day wash-out period. Victim and perpetrator compounds warfarin Subjects receive two different victim compounds (lisinopril and warfarin) and two different perpetrator compounds (placebo semaglutide with carrier and oral semaglutide). Each dosing occasion is separated by a 7-day wash-out period.
- Primary Outcome Measures
Name Time Method Area under the S-warfarin concentration-time curve From dosing to infinity calculated from a 0-168 hours S-warfarin concentration-time-curve based on 18 sampling time points Area under the R-warfarin concentration-time curve From dosing to infinity calculated from a 0-168 hours S-warfarin concentration-time-curve based on 18 sampling time points Area under the lisinopril concentration-time curve From dosing to infinity calculated from a 0-60 hours lisinopril concentration-time-curve based on 13 sampling time points
- Secondary Outcome Measures
Name Time Method Maximum observed S-warfarin plasma concentration 0 to 168 hours after single dose Maximum observed R-warfarin plasma concentration 0 to 168 hours after single dose Maximum observed lisinopril plasma concentration 0 to 60 hours after single dose
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Berlin, Germany