check_circleStudy Completed
Obstructive sleep apnea
Bayer Identifier:
20906
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
MaleAge
20 - 45 YearsTrial summary
Enrollment Goal
36Trial Dates
May 2021 - August 2021Phase
Phase 1Could I Receive a placebo
YesProducts
BAY2586116Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | SOUSEIKAI Fukuoka Mirai Hospital | Fukuoka, 813-0017, Japan |
Primary Outcome
- Number of participants with adverse eventsdate_rangeTime Frame:From first administration up to 8 days after last dose (follow-up visit)
Secondary Outcome
- Cmax of BAY2586116Cmax: maximum observed drug concentration in measured matrix after single dose administration.date_rangeTime Frame:Day 1
- Cmax/D of BAY2586116Cmax/d: Cmax divided by dose.date_rangeTime Frame:Day 1
- AUC of BAY2586116AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose.date_rangeTime Frame:Day 1
- AUC/D of BAY2586116AUC/D: AUC divided by dose.date_rangeTime Frame:Day 1
- Cmax,md of BAY2586116Only for Dose step 3.date_rangeTime Frame:Day 5
- Cmax,md/D of BAY2586116Only for Dose step 3.date_rangeTime Frame:Day 5
- AUCτ,md of BAY2586116Only for Dose step 3. AUCτ,md: AUC during any planned dose interval after multiple dose.date_rangeTime Frame:Day 5
- AUCτ,md/D of BAY2586116Only for Dose step 3. AUCτ,md/D: AUCτ,md divided by dose.date_rangeTime Frame:Day 5
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
3