BAY2586116の安全性、身体への影響、様々な投与量における体内への侵入、体内通過、体外排出について、健康な日本人男性被験者を対象に鼻腔からの単回投与および複数回投与後の詳細な調査を行う研究

基本情報

NCT ID

NCT04872387

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

Bayer

概要

BAY2586116 is a new drug in development for the treatment of obstructive sleep apnea. This is a condition that causes breathing to repeatedly stop and start during sleep due to blocked upper airways. This is a study to learn more how safe BAY2586116 is, how it affects the body, how it moves into, through and out of the body in healthy Japanese male participants. The participants will be randomly chosen to receive 1 of 3 different doses of BAY2586116 or to receive a placebo. A placebo looks like a treatment but does not have any medicine in it. The participants will receive their study treatment either 1 single time or once a day for 5 days through a nasal spray. The participants will be in the study for a total of about 12 weeks. They will stay at their study site for either 5 or 9 days, depending on which study treatment they receive. During this time, the doctors will take blood and urine samples and check the participants' health. About 6 to 8 days after the participants receive their last treatment, the researchers will check the participants' health again. The main aim of this study is to learn more about how safe BAY2586116 is compared to the placebo. To answer this question, the researchers will count the number of participants who have medical problems that may or may not be related to the study treatment. These medical problems are also known as "adverse events" while they are in the study.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)