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

Completed Phase 1 Last updated 26 January 2023

What this trial tests

Phase 1 trial testing BAY1817080 in Endometriosis Related Pain in 36 participants. Completed in 20 September 2020.

Timeline

15 February 2020

Primary endpoint
20 September 2020

20 September 2020

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	basic science
Enrollment	36
Start date	15 February 2020
Primary completion	20 September 2020
Estimated completion	20 September 2020
Sites	1 location across Japan

Drugs / interventions tested

• BAY1817080 — full drug profile →
• Matching Placebo — full drug profile →

Conditions studied

• Endometriosis Related Pain — all drugs for Endometriosis Related Pain →
• Overactive Bladder — all drugs for Overactive Bladder →
• Diabetic Neuropathic Pain — all drugs for Diabetic Neuropathic Pain →
• Refractory or Unexplained Chronic Cough — all drugs for Refractory or Unexplained Chronic Cough →

Sponsor

Bayer — full company profile →

Who can join

Adults 20 to 45, male only, with Endometriosis Related Pain or Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and efficacy of gefapixant, a novel drug for the treatment of chronic cough: A systematic review and meta-analysis of randomized controlled trials.
   Abu-Zaid A, Aljaili AK, Althaqib A, Adem F, et al · · 2021 · cited 12× · PMID 34012479 · DOI 10.4103/atm.atm_417_20
2. P2X3 Receptor Antagonist Eliapixant in Phase I Clinical Trials: Safety and Inter-ethnic Comparison of Pharmacokinetics in Healthy Chinese and Japanese Participants.
   Li X, Haranaka M, Li H, Liu P, et al · · 2024 · PMID 38907175 · DOI 10.1007/s40262-024-01387-y