BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect

Study Overview
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Brief Summary
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This single center, double-blind, randomized study with up to 11 treatment groups evaluates the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of single ascending doses of BAY2328065

Official Title
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Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BAY2328065 Including the Relative Bioavailability Between Solution and Tablet Formulation and the Effect of Food on the Pharmacokinetics of BAY2328065 in Healthy Men

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: BAY2328065
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers, aged 18 - 45 years Body mass index (BMI): 18 ≤ BMI ≤ 30 kg/m² Smoking less than 10 cigarettes / day Signed informed consent Use of an accepted method of contraception for the duration of the study. Exclusion Criteria: Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, thyroid disorders or malignant tumors Known severe allergies, non allergic drug reactions, or multiple drug allergies Medication history: any regular medication, esp. drugs known to induce/inhibit liver enzymes or transporters Clinically relevant findings in physical examination; ECG, blood pressure; laboratory values

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br>Study group 1-11 of BAY2328065 (increasing dose levels for study group 2-11) | Drug: BAY2328065<br>* Doses from 2.25-700 mg once daily in an escalating manner as liquid service formulation (LSF) or tablets<br>|
| Placebo Comparator: Placebo<br>Study group 1-11 of Placebo | Drug: Placebo<br>* Matching placebo, once daily in an escalating manner as LSF or tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events | The frequency of adverse events collected from dosing until follow up, i.e. 8 days after dosing | Up to 8 days | 
| Severity of treatment-emergent adverse events | The severity of adverse events collected from dosing until follow up, i.e. 8 days after dosing Severity is assessed by the following criteria: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability / incapacity Is a congenital anomaly / birth defect Is another serious or important medical event as judged by the investigator | Up to 8 days |