Status:
COMPLETED
A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study looks at the way a new medicine tablet called semaglutide moves in and throughout the body over time. It will also look at if the medicine is safe and the body can accept it. The new medici...
Eligibility Criteria
Inclusion
- Chinese male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body weight equal to or above 54.0 kg
- Body mass index (BMI) between 20.0 and 24.9 kg/m\^2 (both inclusive)
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods
- History of pancreatitis (acute or chronic) as declared by the subject.
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) as declared by the subject.
- History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) as declared by the subject.
- History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) as declared by the subject.
- Smoker (defined as a subject who is smoking equal to or more than 1 cigarette or the equivalent per day).
- Unable or unwilling to refrain from smoking and use of nicotine substitute products during the inpatient periods, as judged by the investigator.
- Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening.
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04016974
Start Date
October 8 2019
End Date
February 26 2021
Last Update
July 12 2024
Active Locations (1)
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1
Beijing Hospital-phase I
Beijing, Beijing Municipality, China, 100730