A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: t
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• 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.
Locations
Other Locations
Canada
Altasciences
RECRUITING
Montreal
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date:2024-10-15
Estimated Completion Date:2025-05-25
Participants
Target number of participants:90
Treatments
Experimental: Sequence 1: Semaglutide J then Semaglutide L
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2.
Experimental: Sequence 2: Semaglutide L then Semaglutide J
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2.
Experimental: Sequence 3: Semaglutide J then Semaglutide M
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2.
Experimental: Sequence 4: Semaglutide M then Semaglutide J
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2.
Experimental: Sequence 5: Semaglutide J then Semaglutide N
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2.
Experimental: Sequence 6: Semaglutide N then Semaglutide J
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then semaglutide J in treatment period 2.