Clinical trial NCT04872387: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Phase I study
Japanese healthy volunteer study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation (including medical and surgical history, physical examination, laboratory tests, ECG, vital signs).
* Participant must be 20 to 45 years of age inclusive, at the time of signing the ICF.
* BMI above or equal 18.0 and below or equal 29.9 kg/m² at screening.
* Male.
* Japanese.
* Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* A sexually active man who has not been surgically sterilized has to agree not to act as sperm donor for the time period between signing of the ICF and 90 days after the last administration of study intervention.

Key Exclusion Criteria:

* A history of relevant diseases of vital organs, of the CNS (central nervous system) or other organs.
* Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
* Given the nasal administration route, these diseases include (but are not limited to) any symptomatic and/or a history of relevant diseases of the ear, nose, and throat area (e.g. acute allergic rhinitis, acute infectious rhinitis, acute or chronical sinusitis, infection of the upper respiratory tract, symptomatic deviation of the nasal septum or a different relevant impairment of nasal breathing, history of any surgery of the ear, nose, and throat area \[exception: sole history of adenectomy and/or tonsillectomy and/or paracentesis \>1 year prior to 1st administration of study intervention\], anatomical abnormalities of the ear, nose, and throat area \[e.g. surgical corrected or uncorrected cheilognathopalatoschisis\]).
* Liver insufficiency or active liver disease, which may include unexplained persistent transaminase elevations.
* Known or suspected liver disorders (e.g. Morbus Gilbert/Meulengracht) and bile secretion/flow (cholestasis, also history of it).
* Participants with thyroid disorders as evidenced by assessment of thyroid stimulating hormone levels outside the normal reference range at screening.
* Personal or familial history of genetically muscular diseases.
* History of autoimmune disease.
* Known hypersensitivity to the study interventions (active substances or excipients of the preparations).
* Known severe allergies, e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract, allergic asthma, allergies requiring therapy with corticosteroids, urticarial, or significant non-allergic drug reactions.
* History of known or suspected malignant tumors.
* Tendency for vasovagal reactions (e.g. after venipuncture) or history of syncope.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: From first administration up to 8 days after last dose (follow-up visit)
Secondary outcomes:
measure: Cmax of BAY2586116
timeFrame: Day 1
measure: Cmax/D of BAY2586116
timeFrame: Day 1
measure: AUC of BAY2586116
timeFrame: Day 1
measure: AUC/D of BAY2586116
timeFrame: Day 1
measure: Cmax,md of BAY2586116
timeFrame: Day 5
measure: Cmax,md/D of BAY2586116
timeFrame: Day 5
measure: AUCτ,md of BAY2586116
timeFrame: Day 5
measure: AUCτ,md/D of BAY2586116
timeFrame: Day 5
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: SOUSEIKAI Fukuoka Mirai Hospital
Study officials:
References: