check_circleStudy Completed

Endometriosis related pain, Overactive bladder, Diabetic neuropathic pain, Refractory or unexplained chronic cough

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)

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 54 Years

Trial summary

Enrollment Goal
14
Trial Dates
August 2020 - February 2021
Phase
Phase 1
Could I Receive a placebo
No
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
PRAHealthSciencesGRONINGEN, 9728 NZ, Netherlands

Primary Outcome

  • AUC of BAY1817080 in plasma (Part A)
    Area under the concentration vs. time curve
    date_rangeTime Frame:
    Pre-dose, post-dose on Day 1 (up to 16 hours), Days 2 to 4 (every 12 hours)
  • Maximum observed concentration of BAY1817080 in plasma (Cmax) (Part A)
    date_rangeTime Frame:
    Pre-dose, post-dose on Day 1 (up to 16 hours), Days 2 to 4 (every 12 hours)
  • Radioactivity excreted in urine of BAY1817080 and its metabolites as a percentage of the dose (%AE,ur) (Part B)
    date_rangeTime Frame:
    Pre-dose, Day 1 (0-12 h and 12-24 h), Days 2 to 15, 22, 29, 36, 43
  • Radioactivity excreted in feces of BAY1817080 and its metabolites as a percentage of the dose (%AE,fec) (Part B)
    date_rangeTime Frame:
    Pre-dose, Days 1 to 15, 22, 29, 36, 43
  • Radioactivity excreted in vomit (if applicable) of BAY1817080 and its metabolites as a percentage of the dose (%AE,v) (Part B)
    date_rangeTime Frame:
    Up to 12 hours post-dose
  • Whole blood to plasma ratio of total radioactivity (Part B)
    date_rangeTime Frame:
    Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15, 22, 29, 36, 43
  • AUC of [14C]BAY1817080 in Plasma (Part B)
    date_rangeTime Frame:
    Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15
  • Cmax of [14C]BAY1817080 in plasma (Part B)
    date_rangeTime Frame:
    Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15
  • AUC of total radioactivity (Part B)
    date_rangeTime Frame:
    Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15, 22, 29, 36, 43
  • Cmax of total radioactivity (Part B)
    date_rangeTime Frame:
    Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15, 22, 29, 36, 43

Secondary Outcome

  • Number of participants with Treatment-emergent adverse events (TEAEs) (Part A)
    date_rangeTime Frame:
    From first dose up to Day 15
  • Number of participants with maximum severity of TEAEs (Part A)
    date_rangeTime Frame:
    From first dose up to Day 15
  • Number of participants with TEAEs (Part B)
    date_rangeTime Frame:
    From first dose up to Day 15
  • Number of participants with maximum severity of TEAEs (Part B)
    date_rangeTime Frame:
    From first dose up to Day 15

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Non-randomized
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
2