NCT04265781

Study on the Safety of Drug BAY1817080 at Different Doses and the Way the Body Absorbs and Eliminates the Drug in Japanese Healthy Adult Male Participants

Phase 1 Dose Escalation Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of BAY 1817080 in Japanese Healthy Adult Male Participants in a Single-center, Randomized, Single-blind, Placebo-controlled Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Researchers in this study want to learn about the safety of drug BAY1817080 at different doses and the resulting blood levels of the study drug in Japanese healthy adult male participants. Study drug BAY1817080 is a drug under development with a goal to suppress pain and chronic cough. It works by binding to and blocking proteins expressed on the sensory nerves of the womb tissue, bladder or airway which are oversensitive in the patients with endometriosis (a condition where the tissue that usually grows inside the womb grows outside of the womb), overactive bladder (a condition that causes a sudden urge to urinate often or more frequently) and long-standing cough with or without clear causes. Participants in this study will receive either the study drug or placebo tablets (a placebo looks like the test drug but does not have any medicine in it). The dosage will be either one single dose of study drug/placebo received on only one day or multiple doses of study drug/placebo received twice daily for 13 days plus one dose in the morning of the 14th day. The total study duration for each participant will be usually no more than 42 days. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

Conditions

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

Interventions

Type	Name	Description
DRUG	BAY1817080	Three different doses over the course of study
DRUG	Matching Placebo	Matching Placebo to BAY1817080

Timeline

• Start date: 2020-02-15
• Primary completion: 2020-09-20
• Completion: 2020-09-20
• First posted: 2020-02-12
• Last updated: 2023-01-26

Locations

1 site across 1 country: Japan