check_circleStudy Completed

Obstructive sleep apnea

A study to learn more about how safe BAY2586116 is, how it affects the body, how it moves into, through and out of the body at different doses in healthy Japanese male participants after taking single and multiple doses through the nose

Trial purpose

BAY2586116 is a new drug in development for the treatment of obstructive sleep apnea. This is a condition that causes breathing to repeatedly stop and start during sleep due to blocked upper airways.

This is a study to learn more how safe BAY2586116 is, how it affects the body, how it moves into, through and out of the body in healthy Japanese male participants.

The participants will be randomly chosen to receive 1 of 3 different doses of BAY2586116 or to receive a placebo. A placebo looks like a treatment but does not have any medicine in it. The participants will receive their study treatment either 1 single time or once a day for 5 days through a nasal spray.

The participants will be in the study for a total of about 12 weeks. They will stay at their study site for either 5 or 9 days, depending on which study treatment they receive. During this time, the doctors will take blood and urine samples and check the participants' health. About 6 to 8 days after the participants receive their last treatment, the researchers will check the participants' health again.

The main aim of this study is to learn more about how safe BAY2586116 is compared to the placebo. To answer this question, the researchers will count the number of participants who have medical problems that may or may not be related to the study treatment. These medical problems are also known as “adverse events” while they are in the study.

Key Participants Requirements

Sex

Male

Age

20 - 45 Years

Trial summary

Enrollment Goal
36
Trial Dates
May 2021 - August 2021
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY2586116
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
SOUSEIKAI Fukuoka Mirai HospitalFukuoka, 813-0017, Japan

Primary Outcome

  • Number of participants with adverse events
    date_rangeTime Frame:
    From first administration up to 8 days after last dose (follow-up visit)

Secondary Outcome

  • Cmax of BAY2586116
    Cmax: maximum observed drug concentration in measured matrix after single dose administration.
    date_rangeTime Frame:
    Day 1
  • Cmax/D of BAY2586116
    Cmax/d: Cmax divided by dose.
    date_rangeTime Frame:
    Day 1
  • AUC of BAY2586116
    AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose.
    date_rangeTime Frame:
    Day 1
  • AUC/D of BAY2586116
    AUC/D: AUC divided by dose.
    date_rangeTime Frame:
    Day 1
  • Cmax,md of BAY2586116
    Only for Dose step 3.
    date_rangeTime Frame:
    Day 5
  • Cmax,md/D of BAY2586116
    Only for Dose step 3.
    date_rangeTime Frame:
    Day 5
  • AUCτ,md of BAY2586116
    Only for Dose step 3. AUCτ,md: AUC during any planned dose interval after multiple dose.
    date_rangeTime Frame:
    Day 5
  • AUCτ,md/D of BAY2586116
    Only for Dose step 3. AUCτ,md/D: AUCτ,md divided by dose.
    date_rangeTime Frame:
    Day 5

Trial design

Randomized, placebo-controlled, single-blind, dose escalation study to investigate the safety, tolerability, and pharmacokinetics after single and multiple nasal doses of BAY 2586116 in Japanese healthy male participants
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
3