Phase 1 study of BAY 2395840 in Japanese healthy male participants

JRCT ID: jRCT2071220060

Registered date:18/10/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetic neuropathic pain
• Date of first enrollment: 11/10/2022
• Target sample size: 36
• Study type: Interventional

Intervention(s)

- Dose step 1: Each participant will receive an single dose (SD) of dose 1 of
BAY2395840 or matching placebo.
- Dose step 2: Each participant will receive an single dose (SD) of dose 2 of
BAY2395840 or matching placebo.
- Dose step 3: Each participant will receive an single dose (SD) of dose 3 of
BAY2395840 or matching placebo.
- Dose step 4:Each participant will receive multiple doses (MDs) of dose 3 of BAY2395840 or matching placebo.

Outcome(s)

• Primary Outcome: Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: 10 to 14 days after last administration of study intervention ]

Secondary Outcome

- Cmax (maximum observed drug concentration in measured matrix after single dose administration) of BAY2395840 [ Time Frame: On day 1]
- AUC (area under the concentration vs. time curve from zero to infinity after single (first) dose) of BAY2395840 [ Time Frame: On day 1]
- AUC(0-24) (AUC from time 0 to 24 h after single dosing) of BAY2395840 [ Time Frame: On day 1]
- Cmax,md (Cmax after MD administration during a dosage interval, directly taken from analytical data) of BAY2395840 (only for Dose step 4) [ Time Frame: On day 7 ]
- AUC(0-24)md (AUC from time 0 to 24 h after multiple dosing) of BAY2395840 (only for Dose step 4) [ Time Frame: On day 7]

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs (BP and pulse rate), 12-lead ECG, and laboratory tests. Re-screening will be allowed.
- Ethnicity: Japanese
- Participant must be 20 to 45 years of age inclusive, at the time of signing the informed consent.
- BMI above or equal 18.0 kg/m^2 and below or equal 29.9 kg/m^2 at screening
- Male
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Study participants of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the ICF and 90 days after administration of the study intervention. Acceptable methods of contraception include, but are not limited to: (i) condoms (male or female); (ii) intra-uterine device; (iii) hormone-based contraception. Study participants of reproductive potential must agree to utilize 2 reliable and acceptable methods of contraception simultaneously including condoms.
- 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.

Exclude criteria

- Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests, and 12-lead ECG) deviating from normal and deemed to be of clinical relevance by the investigator.
- Relevant diseases within the last 4 weeks prior to first administration of study intervention.
- Known severe allergies.
- Regular use of therapeutic or recreational drugs.
- Suspicion of drug or alcohol abuse.
- Positive cotinine test.
- Donation of more than 200 mL of blood within 4 weeks before first administration of study intervention, donation of more than 400 mL of blood within 3 months before first administration of study intervention, or plasmapheresis within 3 months prior to first administration of study intervention.
- Intake of foods or beverages containing grapefruit, pomelo, tangelo, or Seville oranges from 7 days before first administration of the study intervention up to the last time point of PK sampling after the last administration of the study intervention.
- Special diets preventing the participants from eating the standard meals during the study conduct.
- Participation in a clinical study of an investigational drug within 4 months or of an approved drug within 3 months before the first administration of study intervention.
- Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participants safety.
- Participant is in custody by order of an authority or a court of law.
- Participant is an employee of the sponsor or of a CRO conducting the study, or has a close affiliation with the investigational site.
- Unable/unwilling to comply with study restrictions

Related Information

• Primary Sponsor: Myoishi Masafumi
• Secondary ID(s): NCT05563454