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A Study to Learn More About How Safe BAY2586116 is, How it Affects the Body, How it Moves Into, Through and Out of the Body at Different Doses in Healthy Japanese Male Participants After Taking Single and Multiple Doses Through the Nose

NCT04872387 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-03-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

BAY2586116

Nasal administration

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-11
Primary Completion
2021-08-04
Completion
2021-08-26

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04872387 on ClinicalTrials.gov