First in Human Study to Investigate the Safety and Tolerability, Pharmacokinetics, Itraconazole Drug-drug-interaction and Food Effect of BAY1817080

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 of ascending single doses of BAY1817080 using a placebo controlled, randomized, single center design. In addition the influence of itraconazole and food on the pharmacokinetics of BAY1817080 will be investigated.

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 (10 - 1500 mg, Tablets) of BAY1817080 Including the Effect of Food and Itraconazole on the Relative Bioavailability of BAY1817080 in Healthy Men

Conditions
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Clinical Trials, Phase I as Topic

Intervention / Treatment
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* Drug: BAY1817080
* Drug: Placebo
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects Age: 18 to 45 years (inclusive) Body mass index (BMI) : ≥18 and ≤30 kg/m² Race: White Exclusion Criteria: Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance Relevant diseases within the last 4 weeks prior to the first drug administration Existing chronic diseases requiring medication Known or suspected malignant tumors or carcinoma in situ (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment) 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 any drugs which might influence the results of the trial within 14 days prior to administration or during the trial until follow-up including drugs which might affect the pharmacokinetics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: BAY1817080<br>Study Part 1: Dose 1 to 7 of BAY1817080 (increasing dose levels; redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food [American breakfast]); Study part 2: Dose 1 to 4 of BAY1817080 together with an American breakfast (increasing dose levels; redosing of BAY1817080 at dose group 1, 2 and 4 together with food [Continental breakfast]) | Drug: BAY1817080<br>* Study part 1: Escalating doses of BAY1817080; single dose administration; solid dosage form (redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food [American breakfast]) Study part 2: Escalating doses of BAY1817080; single dose administration together with an American breakfast; solid dosage form (redosing of BAY1817080 at dose group 1, 2 and 4 together with food [Continental breakfast])<br>Drug: Itraconazole<br>* Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)<br>|
| Placebo Comparator: Placebo<br>Study Part 1: Placebo Dose 1 to 7 of BAY1817080; Study Part 2: Placebo Dose 1 to 4 of BAY1817080 | Drug: Placebo<br>* Study part 1: Escalating doses of respective placebos; single dose administration; solid dosage form (redosing of placebo at dose group 1 and 2 together with itraconazole; redosing of placebo at dose group 4 together with food [American breakfast]) Study part 2: Escalating doses of respective placebos; single dose administration together with an American breakfast; solid dosage form (redosing of placebo at dose group 1, 2 and together with food [Continental breakfast])<br>Drug: Itraconazole<br>* Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)<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 |  | Up to 4 months | 
| Severity of treatment-emergent adverse events |  | Up to 4 months |