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

Phase 1

• Conditions: Familial hypercholesterolaemia, Hypercholesterolaemia

• Registration Number: JPRN-jRCT2071210055
• Lead Sponsor: Sudoh Yuki

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-27
• Study Completion: 2022-01-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 36

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.

Exclusion Criteria

Any disorder, which in the investigators opinion might jeopardise participant safety or compliance with the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified