Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects

Study Overview
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Brief Summary
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To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days

Official Title
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Single/Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY1101042 Given as 5 mg MR Tablet After Single Oral Dosing Followed by Once Daily Dosing for 7 Days in 12 Healthy Male Subjects Per Dose Step in a Randomized, Placebo Controlled, Single Blind, Group Comparison Design

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: BAY1101042
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The informed consent must be signed before any study specific tests or procedures are done. Healthy male subject. Age: 18 to 45 years (inclusive) at the screening. Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2. Ability to understand and follow study-related instructions. Exclusion Criteria: 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. Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening. Regular use of medicines. Smoking more than 10 cigarettes daily. Systolic blood pressure below 100 or above 145 mmHg (at screening). Diastolic blood pressure below 50 or above 90 mmHg (at screening). Heart rate below 50 or above 90 beats/ min (at screening).

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single/multiple doses of 10 mg BAY1101042 or placebo<br>Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days | Drug: BAY1101042<br>* Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days<br>Drug: Placebo<br>* Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)<br>|
| Experimental: Single/ multiple doses of 20 mg BAY1101042 or placebo<br>Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days | Drug: BAY1101042<br>* Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days<br>Drug: Placebo<br>* Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)<br>|
| Experimental: Single/ multiple doses of 30 mg BAY1101042 or placebo<br>Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days | Drug: BAY1101042<br>* Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days<br>Drug: Placebo<br>* Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)<br>|
| Experimental: Single/ multiple doses of 40 mg BAY1101042 or placebo<br>Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days | Drug: BAY1101042<br>* Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days<br>Drug: Placebo<br>* Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)<br>|
| Experimental: Single/ multiple doses of 50 mg BAY1101042 or placebo<br>Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days | Drug: BAY1101042<br>* Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days<br>Drug: Placebo<br>* Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)<br>|
| Experimental: Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo<br>Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days | Drug: BAY1101042<br>* Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days<br>Drug: Placebo<br>* Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events (TEAEs) | Assessment of treatment emergent adverse events from first study drug intake until follow up | Approximately 19 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-24) of BAY1101042 | AUC(0-24): area under the concentration vs. time curve from zero to 24 hours after single dose | At day 1 | 
| AUC(0-24)/D of BAY1101042 | AUC(0-24)/D: dose-normalized area under the concentration vs. time curve from zero to 24 hours after single dose | At day 1 | 
| Cmax of BAY1101042 | Cmax: maximum observed drug concentration after single dose | At day 1 | 
| Cmax/D of BAY1101042 | Cmax/D: dose-normalized maximum observed drug concentration after single dose | At day 1 | 
| AUCτ,md of BAY1101042 | AUCτ,md: area under the concentration vs. time curve for the actual dosing interval after multiple dose | At day 9 | 
| AUCτ,md/D of BAY1101042 | AUCτ,md/D: dose-normalized area under the concentration vs. time curve for the actual dosing interval after multiple dose | At day 9 | 
| Cmax,md of BAY1101042 | Cmax,md: maximum observed drug concentration after multiple dose | At day 9 | 
| Cmax,md/D of BAY1101042 | Cmax,md/D: dose-normalized maximum observed drug concentration after multiple dose | At day 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease