Study on the Safety of the Drug BAY2395840 at Different Doses, the Way the Body Absorbs, Distributes and Excretes the Drug Including the Effect of Its Formulation (Tablet or Liquid) and the Effect of Food on the Absorption, Distribution or Excretion of the Drug in Healthy Male Participants

NCT ID: NCT05517746

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2021-03-11

Brief Summary

Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus. The study treatment, BAY2395840, is being developed to help block certain proteins from causing inflammation and pain in people with endometriosis. But, this is the first time that researchers will study BAY2395840 in humans.

In this study, the researchers will learn how safe BAY2395840 is for the participants to take. They will also learn what happens to BAY2395840 in the body. The study will include about 56 healthy adult men.

All of the participants will take increasing doses of BAY2395840, or a placebo. A placebo looks like a treatment but does not have any medicine in it. Some of the participants will take their study treatment 1 time under diet 1 conditions. The other participants will take their study treatment 7 times with diet 1 or diet 2.

The participants will take BAY2395840 or the placebo as tablets or as a liquid by mouth. The participants will stay at the study site for up to 11 days . After that, they will visit the study site 1 more time. Each participant will be in the study for up to about 14 weeks.

During the study, the doctors will collect blood and urine samples and check the participants' overall health and heart health. The participants will answer questions about how they are feeling, what medications they are taking, and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

Participants received BAY2395840 dose A as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with the same BAY2395840 dose A1 as oral solution under diet 1 conditions (Period 2)

Group Type: EXPERIMENTAL

BAY2395840 tablet

Intervention Type: DRUG

tablets, oral administration

BAY2395840 oral solution

Intervention Type: DRUG

solution, oral administration

Group 2

Participants received BAY2395840 dose C as tablets under diet 1 conditions.

Group Type: EXPERIMENTAL

BAY2395840 tablet

Intervention Type: DRUG

tablets, oral administration

Group 3

Participants received BAY2395840 dose E as tablets under diet 1 conditions.

Group Type: EXPERIMENTAL

BAY2395840 tablet

Intervention Type: DRUG

tablets, oral administration

Group 4

Participants received BAY2395840 dose H as tablets under diet 1 conditions

Group Type: EXPERIMENTAL

BAY2395840 tablet

Intervention Type: DRUG

tablets, oral administration

Group 5

Participants received BAY2395840 dose B as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions

Group Type: EXPERIMENTAL

BAY2395840 tablet

Intervention Type: DRUG

tablets, oral administration

Group 6

Participants received BAY2395840 dose C as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions

Group Type: EXPERIMENTAL

BAY2395840 tablet

Intervention Type: DRUG

tablets, oral administration

Group 7

Participants received BAY2395840 dose I as tablets under diet 1 conditions

Group Type: EXPERIMENTAL

BAY2395840 tablet

Intervention Type: DRUG

tablets, oral administration

Group 8

Participants received BAY2395840 dose G as tablets on Day 1, followed by 3 BAY395840 doses of dose F as tablets on Days 2 to 4 and subsequently 7 further BAY395840 doses of dose G as tablets on Days 5 to 11 under diet 1 conditions

Group Type: EXPERIMENTAL

BAY2395840 tablet

Intervention Type: DRUG

tablets, oral administration

Placebo matching Group 1

Participants received a dose of placebo as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with a single dose of placebo as oral solution under under diet 1 conditions (Period 2)

Group Type: PLACEBO_COMPARATOR

Placebo oral solution

Intervention Type: DRUG

Placebo matching BAY2395840, oral administration

Placebo tablet

Intervention Type: DRUG

Placebo matching BAY2395840, oral administration

Placebo matching Group 2 to 4 and Group 7

Participants received a dose of Placebo as tablets under diet 1 conditions

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DRUG

Placebo matching BAY2395840, oral administration

Placebo matching Group 5 and 6

Participants received Placebo as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DRUG

Placebo matching BAY2395840, oral administration

Placebo matching Group 8

Participants received a dose of Placebo as tablets on Day 1, followed by 3 doses of Placebo as tablets on Days 2 to 4 and subsequently 7 further doses of Placebo as tablets on Days 5 to 11 under diet 1 conditions.

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DRUG

Placebo matching BAY2395840, oral administration

Interventions

BAY2395840 tablet

tablets, oral administration

Intervention Type: DRUG

BAY2395840 oral solution

solution, oral administration

Intervention Type: DRUG

Placebo oral solution

Placebo matching BAY2395840, oral administration

Intervention Type: DRUG

Placebo tablet

Placebo matching BAY2395840, oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male participants of age 18 to 45 years (inclusive), at the time of signing the informed consent.
• Body mass index (BMI) ≥18 kg/m^2 and ≤30 kg/m^2.
• Participants who are overtly healthy.
• Race: White.
• Male participants of reproductive potential who are sexually active must agree to use contraception methods.

Exclusion Criteria

• Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed to be of clinical relevance by the investigator.
• Any known disease that was forbidden in the study as specified in study protocol.
• Any medication or drug use that was forbidden in the study as specified in study protocol.
• Any abnormal finding in Electrocardiogram (ECG), blood pressure or heart rate.
• Any clinical relevant deviation from normal range of laboratory parameters at screening.
• History of COVID-19.
• Prior contact with SARS-CoV-2 positive person or COVID-19 patient within the last 4 weeks prior admission to the ward.
• Positive SARS-CoV-2 viral RNA test.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRS Clinical Research Services Berlin GmbH

Berlin, , Germany

Countries

Germany

Other Identifiers

2019-002573-65

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

19634

Identifier Type: -

Identifier Source: org_study_id