NCT05003440

A Research Study Looking at How the Medicine NNC0385-0434 Works in the Body of Healthy Japanese Men

Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0385-0434 in Healthy, Male Japanese Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to look at how the study medicine works in the body and how it is removed from the body. We are testing the study medicine to make a medicine that can help people lower their cholesterol level. Participants will either get 1. NNC0385-0434 (a potential new medicine) in one of three different doses: 15 mg, 40 mg, or 100 mg. 2. placebo (a dummy medicine which looks like the study medicine but without any medicine). Which treatment participants get is decided by chance. NNC0385-0434 is a new medicine and has not been approved by the Health Authorities (Centre for Drug Evaluation). Participants will get 1 tablet per day for 10 days. The tablet will be handed out by a study doctor or site staff at the clinic and the study will last between 62 and 98 days. Participants will have 7 clinic visits. One of these visits will be a 13-day, 12-night stay (V2) and the rest will be 1-day visits (V1 and V3 to V7). At all visits, except the information visit, participants will have blood drawn along with other clinical checks. Participants will be asked about their health, medical history and habits including mental health.

Conditions

• Healthy Volunteers
• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	NNC0385-0434	Participants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg
DRUG	Placebo	Participants will get 1 tablet (oral use) of placebo per day for 10 days

Timeline

• Start date: 2021-08-19
• Primary completion: 2022-01-19
• Completion: 2022-01-19
• First posted: 2021-08-12
• Last updated: 2024-01-17

Locations

1 site across 1 country: Japan