Status:
COMPLETED
A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The main purpose of the trial is to assess the pharmacokinetics of semaglutide (i.e. the way the drug is distributed in the body over a period of time) following once-weekly administration of semaglut...
Eligibility Criteria
Inclusion
- Healthy male and female Chinese subjects
- Age between 18 to 55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 20 and 24.9 kg/sqm (both inclusive)
- Body weight greater than or equal to 54.0 kg
Exclusion
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including follow-up period. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or barrier methods
- Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
- Use of prescription or non-prescription systemic products (including routine or non-routine vitamins or herbal products) or topical medicinal products (except paracetamol and oral contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2 (randomisation)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- History of pancreatitis (acute or chronic)
- Calcitonin greater than or equal to 50 ng/L
- Blood donation, surgery or trauma with significant blood loss (400 mL) within the last 12 weeks prior to screening
Key Trial Info
Start Date :
September 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03288740
Start Date
September 21 2017
End Date
August 7 2018
Last Update
February 15 2021
Active Locations (1)
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1
Novo Nordisk Investigational Site
Beijing, China, 100730