Status:
COMPLETED
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (C) Semaglutide Tablets
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers
Type 2 Diabetes
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. Besides semaglutide, the current version of the tablet contains 300 m...
Eligibility Criteria
Inclusion
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent.
- Body mass index between 20.0 kg/m\^2 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.
Exclusion
- Glycated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.
- 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 period(s)
- History (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject).
- History (as declared by the subject) or presence of pancreatitis (acute or chronic).
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2021
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT04109508
Start Date
October 2 2019
End Date
January 27 2021
Last Update
February 9 2021
Active Locations (1)
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1
Novo Nordisk Investigational Site
Berlin, Germany, 14050