Status:
COMPLETED
A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers Type 2 Diabetes
Eligibility:
MALE
20-55 years
Phase:
PHASE1
Brief Summary
This study looks at how the new medicine called NNC0480-0389 works in the body of Japanese men when it is given together with semaglutide. Participants will get NNC0480-0389 and semaglutide or 2 doses...
Eligibility Criteria
Inclusion
- Male aged 20-55 years (both inclusive) at the time of signing the informed consent.
- Both parents of Japanese descent.
- Body mass index between 20.0 kg/m\^2 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, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- Glycated haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Key Trial Info
Start Date :
May 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04878406
Start Date
May 18 2021
End Date
July 20 2021
Last Update
May 17 2023
Active Locations (1)
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1
Novo Nordisk Investigational Site
Fukuoka, Japan, 812-0025