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.

NCT04027192 | Completed Phase 1

• 2 other identifiers: 192512019-000940-90
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (4)

• Number of subjects with treatment-emergent adverse events (TEAEs)

  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

• Severity of TEAEs

  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

• AUC(0-12)md (twice daily [BID])

  From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065

• Cmax,md of BAY2328065

  From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065

Study Arms (6)

Bridging part: intervention sequence ABC or BAC

EXPERIMENTAL

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; Drug: BAY2328065 tablet

Multiple dose escalation part: dose 1

EXPERIMENTAL

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; Drug: Placebo LSF

Multiple dose escalation part: dose 2

EXPERIMENTAL

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; Drug: Placebo tablet; Drug: Midazolam

Multiple dose escalation part: dose 3

EXPERIMENTAL

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; Drug: Placebo tablet; Drug: Midazolam

Multiple dose escalation part: dose 4

EXPERIMENTAL

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; Drug: Placebo tablet; Drug: Midazolam

Multiple dose escalation part: dose 5

EXPERIMENTAL

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

Drug: BAY2328065 tablet; Drug: Placebo tablet; Drug: Midazolam

Interventions

BAY2328065 LSF DRUG

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

Bridging part: intervention sequence ABC or BAC; Multiple dose escalation part: dose 1

BAY2328065 tablet DRUG

50 mg tablet, orally

Bridging part: intervention sequence ABC or BAC; Multiple dose escalation part: dose 2; Multiple dose escalation part: dose 3; Multiple dose escalation part: dose 4; Multiple dose escalation part: dose 5

Placebo LSF DRUG

Matching Placebo LSF, orally

Multiple dose escalation part: dose 1

Placebo tablet DRUG

Matching Placebo tablet, orally

Multiple dose escalation part: dose 2; Multiple dose escalation part: dose 3; Multiple dose escalation part: dose 4; Multiple dose escalation part: dose 5

Midazolam DRUG

1 mg per day, orally

Multiple dose escalation part: dose 2; Multiple dose escalation part: dose 3; Multiple dose escalation part: dose 4; Multiple dose escalation part: dose 5

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Open-label crossover in bridging part; double-blind, parallel group in multiple dose escalation part
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 19, 2019
• Study Start: July 31, 2019
• Primary Completion: September 11, 2020
• Study Completion: November 16, 2020
• Last Updated: November 23, 2020

Record last verified: 2020-11

Locations

DE (1)