健康な日本人男性の体内で医薬品NNC0385-0434がどのように作用するかを調べた研究

基本情報

NCT ID

NCT05003440

ステータス

完了

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

36

治験依頼者名

Novo Nordisk A/S

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)