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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Drug: Placebo; Drug: BAY2586116

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 813-0017
    • Souseikai Fukuoka Mirai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAY2586116 Dose step 1 and Placebo; Each participant of Dose step 1 will receive a single dose of BAY2586116 or placebo. In this dose step, 12 participants will be included (9 on active treatment, 3 on placebo).	Drug: Placebo; Matching placebo; Drug: BAY2586116; Nasal administration
Experimental: BAY2586116 Dose step 2 and Placebo; Each participant of Dose step 2 will receive a single dose of BAY2586116 or placebo. In this dose step, 12 participants will be included (9 on active treatment, 3 on placebo).	Drug: Placebo; Matching placebo; Drug: BAY2586116; Nasal administration
Experimental: BAY2586116 Dose step 3 and Placebo; Each participant of Dose step 3 will receive single and multiple doses of BAY2586116 or placebo administered once daily (OD) for 5 consecutive days. In this dose step, 12 participants will be included (9 on active treatment, 3 on placebo).	Drug: Placebo; Matching placebo; Drug: BAY2586116; Nasal administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	From first administration up to 8 days after last dose (follow-up visit)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): August 4, 2021
• Study Completion (Actual): August 26, 2021

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; Phase I study; Japanese healthy volunteer study
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 20906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No