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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.

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ClinicalTrials.gov Identifier: NCT04027192
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: BAY2328065 LSF Drug: BAY2328065 tablet Drug: Placebo LSF Drug: Placebo tablet Drug: Midazolam Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Open-label crossover in bridging part; double-blind, parallel group in multiple dose escalation part
Primary Purpose: Basic Science
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
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : May 22, 2020
Estimated Study Completion Date : July 3, 2020

Arm Intervention/treatment
Experimental: 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)
Drug: BAY2328065 LSF
20 mg/mL LSF (liquid service formulation), orally

Drug: BAY2328065 tablet
50 mg tablet, orally

Experimental: 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

Drug: BAY2328065 LSF
20 mg/mL LSF (liquid service formulation), orally

Drug: Placebo LSF
Matching Placebo LSF, orally

Experimental: 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

Drug: BAY2328065 tablet
50 mg tablet, orally

Drug: Placebo tablet
Matching Placebo tablet, orally

Drug: Midazolam
1 mg per day, orally

Experimental: 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

Drug: BAY2328065 tablet
50 mg tablet, orally

Drug: Placebo tablet
Matching Placebo tablet, orally

Drug: Midazolam
1 mg per day, orally

Experimental: 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

Drug: BAY2328065 tablet
50 mg tablet, orally

Drug: Placebo tablet
Matching Placebo tablet, orally

Drug: Midazolam
1 mg per day, orally

Experimental: 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 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

Drug: BAY2328065 tablet
50 mg tablet, orally

Drug: Placebo tablet
Matching Placebo tablet, orally

Drug: Midazolam
1 mg per day, orally




Primary Outcome Measures :
  1. Number of subjects with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 30 days after end of treatment ]
  2. Severity of TEAEs [ Time Frame: Up to 30 days after end of treatment ]
  3. AUC(0-12)md (twice daily [BID]) [ Time Frame: From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065 ]
  4. Cmax,md of BAY2328065 [ Time Frame: From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027192


Contacts
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Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
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Germany
CRS Clinical Research Services Berlin GmbH Recruiting
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04027192     History of Changes
Other Study ID Numbers: 19251
2019-000940-90 ( EudraCT Number )
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action