PRAHealthSciences
Groningen, 9728 NZ, Netherlands
NCT Number: NCT04487431
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.
Looking for future studies?
Notify Me18 year–54 year
Male
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral single dose
Oral single dose
Time frame: Pre-dose, post-dose on Day 1 (up to 16 hours), Days 2 to 4 (every 12 hours)
Area under the concentration vs. time curve
Time frame: Pre-dose, post-dose on Day 1 (up to 16 hours), Days 2 to 4 (every 12 hours)
Time frame: Pre-dose, Day 1 (0-12 h and 12-24 h), Days 2 to 15, 22, 29, 36, 43
Time frame: Pre-dose, Days 1 to 15, 22, 29, 36, 43
Time frame: Up to 12 hours post-dose
Time frame: Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15, 22, 29, 36, 43
Time frame: Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15
Time frame: Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15
Time frame: Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15, 22, 29, 36, 43
Time frame: Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15, 22, 29, 36, 43
Time frame: From first dose up to Day 15
Time frame: From first dose up to Day 15
Time frame: From first dose up to Day 15
Time frame: From first dose up to Day 15
Bayer
Industry
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04471337
Chronic Disease, Diabetic Neuropathic Pain
Miami, Florida, United States
View Trial DetailsNCT04265781
Diabetic Neuropathic Pain, Endometriosis Related Pain
Fukuoka, Japan
View Trial DetailsNCT04454424
Diabetic Neuropathic Pain, Endometriosis Related Pain
Miami, Florida, United States
View Trial DetailsNCT03204331
Dysmenorrhea, Endometriosis
Andalusia, Alabama, United States
View Trial Details