Clinical trial NCT05517746: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endometriosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 63
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events
timeFrame: Up to 14 days after end of treatment with study medication in the respective period.
measure: Number of participants with treatment-emergent adverse events, categorized by severity.
timeFrame: Up to 14 days after end of treatment with study medication in the respective period.
Secondary outcomes:
measure: Maximum observed drug concentration in plasma (Cmax) after single dose of BAY2395840
timeFrame: Predose up to 192 hours
measure: Area under the concentration vs. time curve from zero to infinity (AUC) in plasma after single dose of BAY2395840
timeFrame: Predose up to 192 hours
measure: Area under the plasma concentration-time curve from zero to 24 hours AUC (0-24) after single dose of BAY2395840
timeFrame: Pre-dose and up to 24 hours post dose
measure: Maximum observed drug concentration in plasma (Cmax) after multiple doses of BAY2395840
timeFrame: Predose up to 192 hours
measure: Area under the plasma concentration-time curve over the last 24-h dosing interval AUC(0-24)in plasma after multiple doses of BAY2395840
timeFrame: Pre-dose and up to 24 hours post dose
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
Study officials:
References: