Status:
COMPLETED
A Trial Investigating the Effect of Probenecid and Ciclosporin on the Concentrations of SNAC in Healthy Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
The aim of the study is to investigate the effect of the medicines, probenecid and ciclosporin on the concentrations of SNAC. SNAC is an ingredient of the semaglutide tablets. Participants will get 3 ...
Eligibility Criteria
Inclusion
- Male or female of non-childbearing potential, aged 18-64 years (both inclusive) at the time of signing informed consent.
- Body mass index between 18.5 and 29.9 kg/sqm (both inclusive).
- Body weight greater than or equal to 50.0 kg.
- 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
- \- Use of tobacco and nicotine products, defined as: A. Smoking more than 1 cigarette or the equivalent per day B. Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period(s).
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- 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).
- Known glucose-6-phosphate-dehydrogenase deficiency (as declared by the subject).
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03466567
Start Date
March 15 2018
End Date
July 10 2018
Last Update
June 19 2019
Active Locations (1)
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1
Novo Nordisk Investigational Site
Berlin, Germany, 14050