NCT04802343

A Trial to Learn How BAY1817080 Moves Into, Through and Out of the Body and How Safe it is in Healthy Chinese Men

A Single-center, Randomized, Placebo-controlled, Parallel-group, Double-blind Study to Investigate the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of BAY 1817080 in Chinese Healthy Adult Male Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Researchers are looking for a better way to treat chronic cough. Before patients with medical conditions can join clinical trials, researchers do trials in healthy participants first to understand how the body acts on the new treatment and learn how safe it is. In this trial, the researchers will study how much of the trial drug, BAY1817080, gets into the blood in a small number of participants. The trial will include about 39 healthy Chinese male who are aged 18 to 45. For this trial participants will be divided in 3 groups. Groups 1 and 2 will take either dose 1 or dose 2 of BAY1817080 or placebo 1 time. Participants of groups 3 will take dose 3 of BAY1817080 or placebo one time at the first day and continue to take dose 3 of BAY1817080 twice a day from day 7 to day 16 of the trial. On day 17 they will take only one dose 3 of BAY1817080. All participants will take BAY1817080 or a placebo as a tablet by mouth. For this trial, the participants in Groups 1 and 2 will stay at the trial site for up to 10 days. The participants in Group 3 will stay at the trial site for up to 26 days. The trial will last up to 4 weeks for the participants in Groups 1 and 2, and 6 weeks for the participants in Group 3. During the trial, the doctors will take blood and urine samples and check the participants blood pressure, pulse rate and electrocardiogram (ECG). The participants will answer questions about how they are feeling to check their general wellbeing.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	BAY1817080	Oral, tablet.
DRUG	Placebo	Oral, tablet.

Timeline

• Start date: 2021-04-02
• Primary completion: 2021-07-19
• Completion: 2021-10-29
• First posted: 2021-03-17
• Last updated: 2022-10-19

Locations

1 site across 1 country: China