A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IV
Phase 1
Recruiting
- Conditions
- Healthy Volunteers Type 2 Diabetes
- Interventions
- Registration Number
- NCT06642584
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted to compare four different tablets containing the investigational medicine semaglutide at the same dose. It is done to test how semaglutide in each of the tablet versions is taken up in the body. Which treatments participants will receive is decided by chance. The study will last for about 28 weeks. The study will enroll healthy male participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 90
Inclusion Criteria
- Male.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria
- Known or suspected hypersensitivity to study interventions or related products.
- Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days prior to first dosing.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 5: Semaglutide J then Semaglutide N Semaglutide B Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2. Sequence 5: Semaglutide J then Semaglutide N Semaglutide J Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2. Sequence 5: Semaglutide J then Semaglutide N Semaglutide N Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2. Sequence 6: Semaglutide N then Semaglutide J Semaglutide B Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then semaglutide J in treatment period 2. Sequence 1: Semaglutide J then Semaglutide L Semaglutide J Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2. Sequence 1: Semaglutide J then Semaglutide L Semaglutide L Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2. Sequence 2: Semaglutide L then Semaglutide J Semaglutide L Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2. Sequence 3: Semaglutide J then Semaglutide M Semaglutide J Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2. Sequence 1: Semaglutide J then Semaglutide L Semaglutide B Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2. Sequence 2: Semaglutide L then Semaglutide J Semaglutide B Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2. Sequence 2: Semaglutide L then Semaglutide J Semaglutide J Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2. Sequence 3: Semaglutide J then Semaglutide M Semaglutide B Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2. Sequence 3: Semaglutide J then Semaglutide M Semaglutide M Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2. Sequence 4: Semaglutide M then Semaglutide J Semaglutide B Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2. Sequence 4: Semaglutide M then Semaglutide J Semaglutide J Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2. Sequence 4: Semaglutide M then Semaglutide J Semaglutide M Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2. Sequence 6: Semaglutide N then Semaglutide J Semaglutide J Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then semaglutide J in treatment period 2. Sequence 6: Semaglutide N then Semaglutide J Semaglutide N Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then semaglutide J in treatment period 2.
- Primary Outcome Measures
Name Time Method Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve From 0 to 24 hours after dosing on Days 122 and 132. Measured in hours nanomoles per liter (h \* nmol/L).
Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration From 0 to 24 hours after dosing on Days 122 and 132. Measured in nanomoles per liter(nmol/L).
Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration From 0 to 24 hours after dosing on Days 122 and 132. Measured in hours.
t½,sema; the terminal half-life of semaglutide From 0 to 840 hours after dosing on Day 132. Measured in hours.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Altasciences
🇨🇦Montreal, Quebec, Canada