Obesity
Conditions
Brief summary
The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as an oral tablet to Japanese participants.
Interventions
DRUGNNC0487-0111
Participants will get one tablet to swallow at the same time of the day.
Participants will get one tablet to swallow at the same time of the day.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria * Male with both parents of Japanese descent * Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive). Body weight equal to or greater than 65.0 kg * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator Key
Exclusion criteria
* Any disorder that in the investigator's opinion might jeopardise participant's safety or compliance with the protocol * Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events (TEAE) | From pre-dose on Day 1 until completion of the end of study visit Day 31 | Number of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose | From pre-dose on Day 10 until Day 11 (24 hours post-dose) | h\*nmol/L |
| Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose | From pre-dose on Day 10 until completion of the end of study visit Day 31 | nmol/L |
| tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose | From pre-dose on Day 10 until completion of the end of study visit Day 31 | hour |
Countries
Japan
Outcome results
None listed