A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05429593
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study will test how the active substances semaglutide and dapagliflozin act in the body (in terms of their levels in the blood), when they are taken in the form of a combination preparation (a tablet with a fixed dose combination) compared to when oral semaglutide and dapagliflozin are given alone.The study will consist of 2 parts. Part 1 will compare semaglutide to the fixed dose combination tablet (semaglutide/dapagliflozin) and part 2 will compare dapagliflozin to the fixed dose combination tablet (semaglutide/dapagliflozin). Participants will take part in either part 1 or part 2.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
- Male or female
- Aged 18-64 years (both inclusive) at the time of signing informed consent.
- Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
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Participation (i.e., signed informed consent) in any other interventional, clinical study within 30 days (or 5 half-lifes of the investigational medicinal product, whichever is longer) before randomisation.
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Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly-effective contraceptive method.
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Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
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Use of tobacco and nicotine products, defined as any of the below:
- Smoking more than 5 cigarettes or the equivalent per day
- Not willing to refrain from smoking and use of nicotine substitute products during the in-house periods
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Blood donation, plasma donation or blood draw, defined as any of the below:
- In excess of 400 mL within the past 90 days prior to the day of screening
- In excess of 50 mL within the past 30 days prior to the day of screening
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History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
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Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 1 sequence A Semaglutide Semaglutide followed by Semaglutide/dapagliflozin Part 1 sequence B Semaglutide/dapagliflozin Semaglutide/dapagliflozin followed by Semaglutide Part 2 sequence B Semaglutide/dapagliflozin Semaglutide/dapagliflozin followed by dapagliflozin Part 2 sequence A Dapagliflozin Dapagliflozin followed by Semaglutide/dapagliflozin
- Primary Outcome Measures
Name Time Method AUC0-24h,sema,ss: area under the semaglutide plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state From 0 to 24 hours on day 49 and 84 in Part 1 measured in h\*nmol/L
AUC0-24h,dapa,ss: area under the dapagliflozin plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state From 0 to 24 hours on day 49 and 98 in Part 2 measured inh\*ng/mL
- Secondary Outcome Measures
Name Time Method Cmax,sema,ss: maximum observed semaglutide plasma concentration during a dosing interval (0 to 24 hours) at steady state) From 0 to 24 hours on day 49 and 84 in Part 1 measured in nmol/L
Cmax,dapa,ss: maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state From 0 to 24 hours on day 49 and 98 in Part 2 measured in ng/mL
tmax,dapa,ss: time to maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state From 0 to 24 hours on day 49 and 98 in Part 2 measured in hours
tmax,sema,ss: time to maximum observed semaglutide plasma concentration during a dosing interval (0 to 24) at steady state From 0 to 24 hours on day 49 and 84 in Part 1 measured in hours
Trial Locations
- Locations (2)
Novo Nordisk Investigational Site
🇩🇪Berlin, Brandenburg, Germany
Parexel International GmbH
🇩🇪Berlin, Germany