NCT04487431

A Trial to Learn How a New Liquid Form of BAY1817080 is Tolerated and Taken up by the Body of Healthy Male Participants (Part A). By Labeling BAY1817080 With a Radioactive Substance (Carbon 14) Researchers Want to Learn How the Study Drug is Processed and Excreted by the Body After Dosing (Part B)

Single-center, Open-label, Non-placebo-controlled, Single-dose Study in Healthy Male Participants to Determine the Pharmacokinetics of BAY 1817080 Oral Solution (Part A) and to Investigate the Pharmacokinetics, Metabolic Disposition and Mass Balance of [14C]BAY 1817080 Oral Solution (Part B)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

Summary

Researchers are looking for a new way to treat people suffering either from a condition where the bladder is unable to hold urine normally (overactive bladder), or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis) or a condition where the cough lasts longer than 8 weeks in adults (chronic cough). BAY1817080 is a new drug that is in development as a potential treatment for these conditions. In this trial, the researchers want to learn how a new liquid form of BAY1817080 is taken up by the body in a small number of healthy participants. The trial will include men who are aged 18 to 54. The trial will have 2 parts: A and B. The participants in Part A will stay at the trial site for about 5 days. During this time, the participants will take 1 dose of a liquid form of BAY1817080 by mouth. The doctors will take blood and urine samples and check the participants' health. Part A will be done so the researchers can see how much BAY1817080 gets into the participants' blood. The participants in Part B will stay at the trial site for about 16 days followed by a maximum of 4 re-admission visits over 24 hours at intervals of 7 days. These participants will take 1 dose of a liquid form of BAY1817080 labeled with a radioactive substance (carbon 14), which means it is "radiolabeled". This allows the researchers to understand how BAY1817080 moves through and leaves the body. During Part B, the doctors will take blood, urine, stool, and vomit samples if applicable. They will also check the participants' health.

Conditions

• Endometriosis Related Pain
• Overactive Bladder
• Diabetic Neuropathic Pain
• Refractory or Unexplained Chronic Cough

Interventions

Type	Name	Description
DRUG	BAY1817080	Oral single dose
DRUG	[14C]BAY1817080	Oral single dose

Timeline

• Start date: 2020-08-05
• Primary completion: 2020-09-30
• Completion: 2021-02-11
• First posted: 2020-07-27
• Last updated: 2023-01-26

Locations

1 site across 1 country: Netherlands