Status:
COMPLETED
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Participants
Eligibility:
MALE
18-64 years
Phase:
PHASE1
Brief Summary
In this study, a known medicine called 'semaglutide' will be tested in two different tablet versions. The two tablets differ in the way these have been manufactured. The aim of the study is to investi...
Eligibility Criteria
Inclusion
- Key inclusion criteria:
- Body mass index (BMI) between 22.0 and 31.9 kilograms per meter square (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 and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- Key exclusion criteria:
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Any disorder 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 before screening.
Exclusion
Key Trial Info
Start Date :
September 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2024
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT06097390
Start Date
September 28 2023
End Date
March 27 2024
Last Update
July 17 2025
Active Locations (1)
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1
Altasciences Clinical Company, Inc
Montreal, Quebec, Canada, H3P 3P1