check_circleStudy Completed

Healthy volunteers

A trial to learn how BAY1817080 moves into, through and out of the body and how safe it is in healthy Chinese men

Trial purpose

Researchers are looking for a better way to treat chronic cough. Before patients with medical conditions can join clinical trials, researchers do trials in healthy participants first to understand how the body acts on the new treatment and learn how safe it is.
In this trial, the researchers will study how much of the trial drug, BAY1817080, gets into the blood in a small number of participants. The trial will include about 39 healthy Chinese male who are aged 18 to 45.
For this trial participants will be divided in 3 groups.
Groups 1 and 2 will take either dose 1 or dose 2 of BAY1817080 or placebo 1 time. Participants of groups 3 will take dose 3 of BAY1817080 or placebo one time at the first day and continue to take dose 3 of BAY1817080 twice a day from day 7 to day 16 of the trial. On day 17 they will take only one dose 3 of BAY1817080.
All participants will take BAY1817080 or a placebo as a tablet by mouth.
For this trial, the participants in Groups 1 and 2 will stay at the trial site for up to 10 days. The participants in Group 3 will stay at the trial site for up to 26 days. The trial will last up to 4 weeks for the participants in Groups 1 and 2, and 6 weeks for the participants in Group 3.
During the trial, the doctors will take blood and urine samples and check the participants blood pressure, pulse rate and electrocardiogram (ECG). The participants will answer questions about how they are feeling to check their general wellbeing.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years

Trial summary

Enrollment Goal
39
Trial Dates
April 2021 - October 2021
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Eliapixant (BAY1817080)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Zhongshan Hospital, Fudan UniversityShanghai, 200032, China

Primary Outcome

  • Cmax of BAY1817080 dose 1 and dose 2 (Day 1)
    Cmax: maximum observed drug concentration in measured matrix after single dose administration
    date_rangeTime Frame:
    Pre-dose on Day 1 to 216 hours post-dose
  • Cmax of BAY1817080 dose 3 (Day 1)
    Cmax: maximum observed drug concentration in measured matrix after single dose administration
    date_rangeTime Frame:
    Pre-dose on Day 1 to 144 hours post-dose
  • AUC of BAY1817080 dose 1 and dose 2 (Day 1)
    AUC: area under the concentration vs. time curve
    date_rangeTime Frame:
    Pre-dose on Day 1 to 216 hours post-dose
  • AUC of BAY1817080 dose 3 (Day 1)
    AUC: area under the concentration vs. time curve
    date_rangeTime Frame:
    Pre-dose on Day 1 to 144 hours post-dose
  • Cmax,md of BAY1817080 in dose 3 cohort (Day 17)
    Cmax,md: maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval, directly taken from analytical data
    date_rangeTime Frame:
    Pre-dose on Day 17 to 12 hours post-dose
  • AUCτ,md of BAY1817080 in dose 3 cohort (Day 17)
    AUCτ,md: the area under the concentration-time curve in the dosing interval after multiple doses
    date_rangeTime Frame:
    Pre-dose on Day 17 to 12 hours post-dose

Secondary Outcome

  • Number of participants with treatment emergent adverse events (TEAEs) with intensity
    date_rangeTime Frame:
    From the first dose of study intervention up to the follow-up visit (up to 30 days)

Trial design

A single-center, randomized, placebo-controlled, parallel-group, double-blind study to investigate the pharmacokinetics, safety and tolerability of single and multiple oral doses of BAY 1817080 in Chinese healthy adult male participants.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
2