Status:
COMPLETED
A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers
Type 2 Diabetes
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the t...
Eligibility Criteria
Inclusion
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 21.0 and 32.0 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
- HbA1c equal to or greater than 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 within 48 hours prior to and during the inpatient periods
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
- History(a) 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(a).
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma(a).
- As declared by the participant or reported in the medical records
Key Trial Info
Start Date :
February 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2023
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT05227196
Start Date
February 4 2022
End Date
August 8 2023
Last Update
September 19 2024
Active Locations (3)
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1
Altasciences Clinical LA, Inc.
Cypress, California, United States, 90630
2
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, United States, 66212
3
Altasciences Company Inc.
Montreal, Quebec, Canada, H3P 3P1