Phase 1 study of BAY 3283142 in Japanese healthy male participants

JRCT ID: jRCT2071230002

Registered date:09/04/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 03/04/2023
• Target sample size: 36
• Study type: Interventional

Intervention(s)

Drug: BAY 3283142
Other: Placebo

Outcome(s)

• Primary Outcome: Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 7 days after end of treatment with study intervention]

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Male

Include criteria

- Participant must be 20 to 50 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12 lead ECG.
- Race: Japanese.
- body mass index (BMI) within the range 18.0 and 29.9 kg/m2 (inclusive).
- Body weight equal or above 55 kg (inclusive).
- Male: Contraceptive use by men and female partners of male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent.

Exclude criteria

- Medical disorder, condition, or history of such that would impair the participants ability to participate or complete this study in the opinion of the investigator.
- A history of clinically relevant diseases of any organs.
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study interventions will not be normal.
- Participants with thyroid disorders as evidenced by assessment of thyroid stimulating hormone levels outside the normal reference range.
- Known hypersensitivity to the study interventions (active substances or excipients of the preparations, e.g., lactose).
- Known severe allergies (e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids), urticaria or significant non-allergic drug reactions.
- Relevant diseases within the last 4 weeks prior to the first intake of study intervention.
- Febrile illness within 2 weeks before the first intake of study intervention.
- Known tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope.
- History of gastrointestinal surgery, with the exception of appendectomy (surgery at least 12 months before screening) and inguinal hernia repair (the surgery at least 12 months before screening with the documentation of no intestine necrosis and no intestine segment resection, and participants must be fully recovered and have no signs or symptoms).
- Acute diarrhea or constipation within 14 days before the first intake of study intervention.
- Regular use of medicines.
- Use of any other systemic or topical medicines or substances which oppose the study objectives.
- Regular use of therapeutic or recreational drugs, e.g., carnitine products, anabolics, high dose vitamins.
- Excluded therapies (e.g., physiotherapy, acupuncture, etc.) within 1 week before the first intake of study intervention.
- Participation in another clinical study of an investigational drug (last dose) within 90 days or 5 half lives of the investigational drug, whichever is longer, before the first dose of this study.
- Exclusion periods from other studies or simultaneous participation in other clinical studies.
- Previous treatment during this study (allowing previously treated participants to be re included into the study may lead to bias).
- Clinically relevant findings in the 12-lead ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over or equal to 120 msec, or of the QTcF or QTcB intervals over 450 msec.
- Clinically relevant arrhythmic disturbances as found in the 12-lead ECGs (especially repeated supra- and ventricular ectopic beats - Lown classification grade 2 or more); known congenital QT prolongation.
- Systolic blood pressure (SBP) below 100 or above 140 mmHg (after 15 min of supine rest).
- Diastolic blood pressure (DBP) below 50 or above 90 mmHg (after 15 min of supine rest).
- Heart rate (HR) below 45 or above 90 bpm (after 15 min of supine rest).
- Clinically relevant findings in the physical examination.
- Positive results for HBsAg, anti-HCV, HIV antigen and antibody, and syphilis (cardiolipin-lecithin antigen, Treponema pallidum antibody).
- Creatine kinase (CK) above upper limit of normal (ULN), except marginal explainable changes which are expected to normalize before study intervention intake.
- Lipase and amylase above ULN (except isolated marginal increases of lipase or amylase to account for variability of the parameters, and the participant is asymptomatic and has no other laboratory changes assuming disease based on medical judgment).
- Glycosylated hemoglobin (HbA1c), serum creatinine, C-reactive protein (CRP), liver enzymes (e.g., alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, total bilirubin) above ULN.
- Deviations from normal ranges of any other safety laboratory parameter indicating apparent disease (or for which disease cannot be excluded) or impacting the objectives of the study.
- Positive urine drug screening indicating drug abuse.
- Positive alcohol breath test.

Related Information

• Primary Sponsor: Myoishi Masafumi
• Secondary ID(s): NCT05800444