Study to Test the Safety of Increasing Multiple Doses of BAY2328065 Given by Mouth, How the Drug is Tolerated and Acts in the Human Body of Healthy Male Participants. Alteration of the Study Drug Effects by Another Drug and the Availability of the Drug Given in Different Formulations is Also Tested.
NCT ID: NCT04027192
Last Updated: 2020-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2019-07-31
2020-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Bridging part: This will be a single-center, randomized, open-label cross-over part with 3 study interventions, 3 intervention periods and 2 intervention sequences.
* Multiple dose escalation part: This will be a single-center, randomized, placebo-controlled, double-blind, parallel group multiple dose escalation part.
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Bridging part: intervention sequence ABC or BAC
10 healthy male participants will be randomly allocated to this arm. The study interventions will follow the sequence ABC or BAC: A: single dose of 50 mg BAY2328065 given as LSF in fasted state B: single dose of 50 mg BAY2328065 given as tablet in fasted state C: single dose of 50 mg BAY2328065 given as tablet in fed state (i.e. after a high caloric and high fat meal)
BAY2328065 LSF
20 mg/mL LSF (liquid service formulation), orally
BAY2328065 tablet
50 mg tablet, orally
Multiple dose escalation part: dose 1
10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day
BAY2328065 LSF
20 mg/mL LSF (liquid service formulation), orally
Placebo LSF
Matching Placebo LSF, orally
Multiple dose escalation part: dose 2
10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction
BAY2328065 tablet
50 mg tablet, orally
Placebo tablet
Matching Placebo tablet, orally
Midazolam
1 mg per day, orally
Multiple dose escalation part: dose 3
10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction
BAY2328065 tablet
50 mg tablet, orally
Placebo tablet
Matching Placebo tablet, orally
Midazolam
1 mg per day, orally
Multiple dose escalation part: dose 4
10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction
BAY2328065 tablet
50 mg tablet, orally
Placebo tablet
Matching Placebo tablet, orally
Midazolam
1 mg per day, orally
Multiple dose escalation part: dose 5
10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo).
The study intervention will be administered with a single dose on the first dosing day followed by a treatment pause of 2 days followed by twice daily doses for 1 day followed by three times daily doses for 9 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction
BAY2328065 tablet
50 mg tablet, orally
Placebo tablet
Matching Placebo tablet, orally
Midazolam
1 mg per day, orally
Interventions
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BAY2328065 LSF
20 mg/mL LSF (liquid service formulation), orally
BAY2328065 tablet
50 mg tablet, orally
Placebo LSF
Matching Placebo LSF, orally
Placebo tablet
Matching Placebo tablet, orally
Midazolam
1 mg per day, orally
Eligibility Criteria
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Inclusion Criteria
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG and vital signs
* Confirmation of the subject's health insurance coverage prior to the first screening examination/visit
* Body mass index (BMI) within the range 18 and 30 kg/m\^2 (inclusive)
* Male participants who are sexually active must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study participant and one method used by the partner) and not to act as sperm donor until follow-up
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
* The informed consent must be signed before any study specific tests or procedures are done
* Ability to understand and follow study-related instructions
Exclusion Criteria
* Relevant diseases within the last 4 weeks prior to start of the first study intervention
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Existing chronic diseases requiring medication
* History of cardiovascular disease
* Known diseases as specified in protocol
* Regular use of therapeutic or recreational drugs
* Suspicion of drug or alcohol abuse
* Smoking equal or more than 10 cigarettes/day
* Clinically relevant findings in Electrocardiogram (ECG), blood pressure, heart rate, physical examination, laboratory examination
* History of COVID-19
* Contact with SARS-CoV-2 positive persons or COVID-19 patients within the last 4 weeks prior admission to the ward
* Positive SARS-CoV-2 viral RNA test
18 Years
50 Years
MALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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CRS Clinical Research Services Berlin GmbH
Berlin, , Germany
Countries
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Other Identifiers
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2019-000940-90
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
19251
Identifier Type: -
Identifier Source: org_study_id