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

NCT05517746 | Completed Phase 1

• 2 other identifiers: 196342019-002573-65
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-emergent adverse events

  Up to 14 days after end of treatment with study medication in the respective period.

• Number of participants with treatment-emergent adverse events, categorized by severity.

  Up to 14 days after end of treatment with study medication in the respective period.

Secondary Outcomes (5)

• Maximum observed drug concentration in plasma (Cmax) after single dose of BAY2395840

  Predose up to 192 hours

• Area under the concentration vs. time curve from zero to infinity (AUC) in plasma after single dose of BAY2395840

  Predose up to 192 hours

• Area under the plasma concentration-time curve from zero to 24 hours AUC (0-24) after single dose of BAY2395840

  Pre-dose and up to 24 hours post dose

• Maximum observed drug concentration in plasma (Cmax) after multiple doses of BAY2395840

  Predose up to 192 hours

• Area under the plasma concentration-time curve over the last 24-h dosing interval AUC(0-24)in plasma after multiple doses of BAY2395840

  Pre-dose and up to 24 hours post dose

Study Arms (12)

Group 1

EXPERIMENTAL

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)

Drug: BAY2395840 tablet; Drug: BAY2395840 oral solution

Group 2

EXPERIMENTAL

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

Drug: BAY2395840 tablet

Group 3

EXPERIMENTAL

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

Drug: BAY2395840 tablet

Group 4

EXPERIMENTAL

Participants received BAY2395840 dose H as tablets under diet 1 conditions

Drug: BAY2395840 tablet

Group 5

EXPERIMENTAL

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

Drug: BAY2395840 tablet

Group 6

EXPERIMENTAL

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

Drug: BAY2395840 tablet

Group 7

EXPERIMENTAL

Participants received BAY2395840 dose I as tablets under diet 1 conditions

Drug: BAY2395840 tablet

Group 8

EXPERIMENTAL

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

Drug: BAY2395840 tablet

Placebo matching Group 1

PLACEBO COMPARATOR

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)

Drug: Placebo oral solution; Drug: Placebo tablet

Placebo matching Group 2 to 4 and Group 7

PLACEBO COMPARATOR

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

Drug: Placebo tablet

Placebo matching Group 5 and 6

PLACEBO COMPARATOR

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

Drug: Placebo tablet

Placebo matching Group 8

PLACEBO COMPARATOR

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.

Drug: Placebo tablet

Interventions

BAY2395840 tablet DRUG

tablets, oral administration

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6; Group 7; Group 8

BAY2395840 oral solution DRUG

solution, oral administration

Group 1

Placebo oral solution DRUG

Placebo matching BAY2395840, oral administration

Placebo matching Group 1

Placebo tablet DRUG

Placebo matching BAY2395840, oral administration

Placebo matching Group 1; Placebo matching Group 2 to 4 and Group 7; Placebo matching Group 5 and 6; Placebo matching Group 8

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: December 18, 2019
• Primary Completion: December 17, 2020
• Study Completion: March 11, 2021
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)