Investigation of safety, tolerability and pharmacokinetic properties of multiple doses of oral NNC0385-0434 in healthy, male Japanese participants

Sudoh Yuki0 sites36 target enrollmentAugust 27, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Sudoh Yuki
Enrollment: 36
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The conclusions of this study that investigates the safety, tolerability and pharmacokinetic properties, and explores the pharmacodynamic effects of multiple doses of oral NNC0385-0434 (15, 40 and 100 mg) in healthy, male Japanese participants are: -Multiple once daily oral NNC0385-0434 doses of up to 100 mg were well-tolerated and no safety concerns were identified. -No deviation from dose proportionality was observed in NNC0385-0434 exposure. -Median NNC0385-0434 half-life ranged from 186 to 203 hours

Registry

who.int

Start Date

August 27, 2021

End Date

January 19, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Sudoh Yuki

Eligibility Criteria

Inclusion Criteria

•1\. Informed consent obtained before any study\-related activities. Study\-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
•2\. Male, aged 20\-55 years (both inclusive) at the time of signing informed consent.
•3\. Both parents of Japanese descent.
•4\. Body weight \>\=54\.0 kg
•5\. Body mass index (BMI) between 20\.0 and 34\.9 kg/m2 (both inclusive)
•6\. Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.