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

Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single and Multiple Oral Doses of BAY 2395840 Including the Relative Bioavailability Between Solution and Tablet Formulation and the Effect of Food on the Pharmacokinetics of BAY 2395840 in Healthy Men

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: BAY2395840 tablet; Drug: BAY2395840 oral solution; Drug: Placebo oral solution; Drug: Placebo tablet

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • CRS Clinical Research Services Berlin GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: BAY2395840 tablet; tablets, oral administration; Drug: BAY2395840 oral solution; solution, oral administration
Experimental: Group 2; Participants received BAY2395840 dose C as tablets under diet 1 conditions.	Drug: BAY2395840 tablet; tablets, oral administration
Experimental: Group 3; Participants received BAY2395840 dose E as tablets under diet 1 conditions.	Drug: BAY2395840 tablet; tablets, oral administration
Experimental: Group 4; Participants received BAY2395840 dose H as tablets under diet 1 conditions	Drug: BAY2395840 tablet; tablets, oral administration
Experimental: Group 5; 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; tablets, oral administration
Experimental: Group 6; 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; tablets, oral administration
Experimental: Group 7; Participants received BAY2395840 dose I as tablets under diet 1 conditions	Drug: BAY2395840 tablet; tablets, oral administration
Experimental: 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	Drug: BAY2395840 tablet; tablets, oral administration
Placebo Comparator: 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)	Drug: Placebo oral solution; Placebo matching BAY2395840, oral administration; Drug: Placebo tablet; Placebo matching BAY2395840, oral administration
Placebo Comparator: Placebo matching Group 2 to 4 and Group 7; Participants received a dose of Placebo as tablets under diet 1 conditions	Drug: Placebo tablet; Placebo matching BAY2395840, oral administration
Placebo Comparator: 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	Drug: Placebo tablet; Placebo matching BAY2395840, oral administration
Placebo Comparator: 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.	Drug: Placebo tablet; Placebo matching BAY2395840, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	AUC from time 0 to 24 hours	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	AUC from time 0 to 24 hours	Pre-dose and up to 24 hours post dose

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): March 11, 2021

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis; Pharmaceutical Solutions
• Other Study ID Numbers: 19634; 2019-002573-65 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No