Phase 1 study of BAY 2586116 in Japanese healthy male participants
- Conditions
- Obstructive sleep apnea Drug
- Registration Number
- JPRN-jRCT2071210020
- Lead Sponsor
- Myoishi Masashi
- Brief Summary
The nasal administration of BAY2586116 as SDs, or MD (OD for 5 consecutive days) was safe and systemically and locally well tolerated in Japanese healthy male participants. - BAY2586116 was well absorbed after nasal administration of single and multiple doses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 36
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.
- 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 & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method