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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06049329
Other study ID # NN9487-5022
Secondary ID U1111-1284-5901
Status Completed
Phase Phase 1
First received
Last updated
Start date September 14, 2023
Est. completion date December 15, 2023

Study information

Verified date March 2024
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 15, 2023
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
NNC0487-0111
Participants will get one tablet to swallow at the same time of the day.
Placebo (NNC0487-0111)
Participants will get one tablet to swallow at the same time of the day.

Locations

Country Name City State
Japan Hakata Clinic Fukuoka

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of treatment emergent adverse events (TEAE) Number of events From pre-dose on Day 1 until completion of the end of study visit Day 31
Secondary AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose h*nmol/L From pre-dose on Day 10 until Day 11 (24 hours post-dose)
Secondary Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose nmol/L From pre-dose on Day 10 until completion of the end of study visit Day 31
Secondary tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose hour From pre-dose on Day 10 until completion of the end of study visit Day 31
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