Back to resultsStudy 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.
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BAY2328065 LSF
BAY2328065 tablet
Placebo LSF
Placebo tablet
Midazolam
Sponsored by
About this trial
This is an interventional basic science trial for Endometriosis
Eligibility Criteria
Inclusion Criteria:
- Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent
- 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:
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal
- 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
Sites / Locations
- CRS Clinical Research Services Berlin GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Bridging part: intervention sequence ABC or BAC
Multiple dose escalation part: dose 1
Multiple dose escalation part: dose 2
Multiple dose escalation part: dose 3
Multiple dose escalation part: dose 4
Multiple dose escalation part: dose 5
Arm Description
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)
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
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
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
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
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
Outcomes
Primary Outcome Measures
Number of subjects with treatment-emergent adverse events (TEAEs)
Severity of TEAEs
AUC(0-12)md (twice daily [BID])
Cmax,md of BAY2328065
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04027192
Brief Title
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.
Official Title
Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate Safety, Tolerability and Pharmacokinetics of Increasing Multiple Oral Doses of BAY2328065 Including the CYP3A4 Induction Potential of BAY2328065 and Randomized Cross-over Investigation of the Relative Bioavailability Between Solution and Tablet Formulation in Healthy Male Participants
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
September 11, 2020 (Actual)
Study Completion Date
November 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as tablet or solution over 12 days to healthy male participants. Researcher want to study how the body absorbs, breaks down and excrete the new drug, also when given together with a test meal. In addition the study will investigate changes that take place in the body when BAY2328065 is given together with another drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
The study will be performed in 2 study parts. Each participant will take part in one study part only.
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Open-label crossover in bridging part; double-blind, parallel group in multiple dose escalation part
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bridging part: intervention sequence ABC or BAC
Arm Type
Experimental
Arm Description
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)
Arm Title
Multiple dose escalation part: dose 1
Arm Type
Experimental
Arm Description
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
Arm Title
Multiple dose escalation part: dose 2
Arm Type
Experimental
Arm Description
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
Arm Title
Multiple dose escalation part: dose 3
Arm Type
Experimental
Arm Description
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
Arm Title
Multiple dose escalation part: dose 4
Arm Type
Experimental
Arm Description
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
Arm Title
Multiple dose escalation part: dose 5
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
BAY2328065 LSF
Intervention Description
20 mg/mL LSF (liquid service formulation), orally
Intervention Type
Drug
Intervention Name(s)
BAY2328065 tablet
Intervention Description
50 mg tablet, orally
Intervention Type
Drug
Intervention Name(s)
Placebo LSF
Intervention Description
Matching Placebo LSF, orally
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Intervention Description
Matching Placebo tablet, orally
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
1 mg per day, orally
Primary Outcome Measure Information:
Title
Number of subjects with treatment-emergent adverse events (TEAEs)
Time Frame
From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant
Title
Severity of TEAEs
Time Frame
From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant
Title
AUC(0-12)md (twice daily [BID])
Time Frame
From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065
Title
Cmax,md of BAY2328065
Time Frame
From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent
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:
Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal
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
Facility Information:
Facility Name
CRS Clinical Research Services Berlin GmbH
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Availability of this study's data will 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.
Learn more about this trial
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.
We'll reach out to this number within 24 hrs