First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845

Study Overview
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Brief Summary
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This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845 using a placebo controlled, randomized, single center design.

Official Title
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Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of Increasing Single Oral Doses of BAY1834845 Including Relative Bioavailability of a Liquid Versus a Solid Dosage in Healthy Male Volunteers

Conditions
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Pelvic Inflammatory Disease

Intervention / Treatment
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* Drug: BAY1834845
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subject Age: 18 to 50 years (inclusive) at the first screening visit Body mass index (BMI) : 18.5 ≤ BMI ≤ 30 kg/m² Exclusion Criteria: Clinically relevant findings in the physical examination Relevant diseases within the last 4 weeks prior to the first study drug administration Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before first study drug administration

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalation/BAY1834845<br>Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day | Drug: BAY1834845<br>* Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group<br>|
| Placebo Comparator: Placebo<br>Subjects will receive a single dose of placebo in the morning of the PK profile day | Drug: Placebo<br>* Single dose of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of treatment-emergent adverse events (TEAEs) | AEs are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication. | Up to 25 days after last drug administration | 
| Severity of treatment-emergent adverse events | The intensity of an AE is classified according to the following categories: Mild Moderate Severe | Up to 25 days after last drug administration | 
| Area under the plasma concentration vs. time curve (AUC) | AUC from zero to infinity after single dose if possible or from time 0 to the last data point above lower limit of quantification (AUC (0-tlast) | Baseline to up to 14 days post drug administration | 
| Maximum drug concentration in plasma after single dose administration (Cmax) | Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845 | Baseline to up to 14 days post drug administration |