Study on the Safety of Drug BAY1817080 at Different Doses and the Way the Body Absorbs and Eliminates the Drug in Japanese Healthy Adult Male Participants

Bayer

Status and phase: Completed; Phase 1

Conditions: Endometriosis Related Pain; Refractory or Unexplained Chronic Cough; Diabetic Neuropathic Pain; Overactive Bladder

Treatments: Drug: Matching Placebo; Drug: BAY1817080

Study type: Interventional

Funder types: Industry

Identifiers

NCT04265781

19738

Details and patient eligibility

About

Researchers in this study want to learn about the safety of drug BAY1817080 at different doses and the resulting blood levels of the study drug in Japanese healthy adult male participants. Study drug BAY1817080 is a drug under development with a goal to suppress pain and chronic cough. It works by binding to and blocking proteins expressed on the sensory nerves of the womb tissue, bladder or airway which are oversensitive in the patients with endometriosis (a condition where the tissue that usually grows inside the womb grows outside of the womb), overactive bladder (a condition that causes a sudden urge to urinate often or more frequently) and long-standing cough with or without clear causes.

Participants in this study will receive either the study drug or placebo tablets (a placebo looks like the test drug but does not have any medicine in it). The dosage will be either one single dose of study drug/placebo received on only one day or multiple doses of study drug/placebo received twice daily for 13 days plus one dose in the morning of the 14th day. The total study duration for each participant will be usually no more than 42 days. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

Enrollment: 36 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant must be 20 to 45 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, vital signs, laboratory tests, and ECG.
• Non-smoker for at least 6 months and with a pack year history of equal to or less than 5 years
• Race: Japanese.
• BMI: above or equal 18.0 and below or equal 30.0 kg/m² at the screening visit.
• Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Men 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 the last administration of study intervention.

Exclusion criteria

• Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance
• Relevant diseases potentially interfering with the study objectives within the 4 weeks before screening or between screening and randomization
• Any febrile illness within the four weeks before screening or between screening and randomization
• Any known presence or history of severe allergies, non-allergic drug reactions, or multiple drug allergies
• Known or suspected malignant tumors or carcinoma in situ
• Any history of malignant tumors
• Any known or suspected benign tumors of the liver and/or pituitary gland
• Known liver disease: existing acute or chronic progressive liver disease, e.g. disturbance of bilirubin excretion (Dubin-Johnson and Rotor syndromes); disturbances of bile secretion and flow (cholestasis); presence or history of liver tumors (benign or malignant). Note: According to this criterion there must have been an interval of at least 6 months between the subsidence of any viral hepatitis (normalization of liver parameters) and the screening visit.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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36 participants in 4 patient groups, including a placebo group

Dose escalation BAY1817080

Experimental group

Description:

Participants receive dose 1 to 3 of BAY1817080 as a single dose on Day 1.

Treatment:

Drug: BAY1817080

Dose expansion BAY1817080

Experimental group

Description:

Participants receive the highest dose 3 of BAY1817080 twice daily (BID) from Day 1 until Day 13 and a single dose on Day 14.

Treatment:

Drug: BAY1817080

Dose escalation Placebo

Placebo Comparator group

Description:

Participants receive placebo tablets orally as a single dose on Day 1.

Treatment:

Drug: Matching Placebo

Dose expansion Placebo

Placebo Comparator group

Description:

Participants receive placebo tablets as BID multiple doses from Day 1 until Day 13 and as a single dose on Day 14.

Treatment:

Drug: Matching Placebo