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)

Completed Phase 1 Last updated 26 January 2023

What this trial tests

Phase 1 trial testing BAY1817080 in Endometriosis Related Pain in 14 participants. Completed in 11 February 2021.

Timeline

5 August 2020

Primary endpoint
30 September 2020

11 February 2021

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	14
Start date	5 August 2020
Primary completion	30 September 2020
Estimated completion	11 February 2021
Sites	1 location across Netherlands

Drugs / interventions tested

• BAY1817080 — full drug profile →
• [14C]BAY1817080 — 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 18 to 54, male only, with Endometriosis Related Pain or Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

1. A Lifelong Impact on Endometriosis: Pathophysiology and Pharmacological Treatment.
   Chen LH, Lo WC, Huang HY, Wu HM. · · 2023 · cited 43× · PMID 37108664 · DOI 10.3390/ijms24087503
2. 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
3. Mass Balance and Metabolic Pathways of Eliapixant, a P2X3 Receptor Antagonist, in Healthy Male Volunteers.
   Reif S, Schultze-Mosgau MH, Engelen A, Piel I, et al · · 2024 · cited 1× · PMID 38044419 · DOI 10.1007/s13318-023-00866-0