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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: BAY1101042; Drug: Placebo

• Registration Number: NCT03252002
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-15
• Study Start: 2017-08-16
• Study First Posted: 2017-08-16
• Primary Completion: 2019-04-30
• Study Completion: 2019-07-24
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-16
• Last Update Posted: 2019-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 96

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single/ multiple doses of 20 mg BAY1101042 or placebo	BAY1101042	Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Single/ multiple doses of 20 mg BAY1101042 or placebo	Placebo	Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Single/ multiple doses of 30 mg BAY1101042 or placebo	BAY1101042	Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Single/ multiple doses of 30 mg BAY1101042 or placebo	Placebo	Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Single/ multiple doses of 40 mg BAY1101042 or placebo	Placebo	Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Single/ multiple doses of 50 mg BAY1101042 or placebo	BAY1101042	Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Single/ multiple doses of 50 mg BAY1101042 or placebo	Placebo	Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Single/multiple doses of 10 mg BAY1101042 or placebo	BAY1101042	Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Single/multiple doses of 10 mg BAY1101042 or placebo	Placebo	Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Single/ multiple doses of 40 mg BAY1101042 or placebo	BAY1101042	Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo	BAY1101042	Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days
Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo	Placebo	Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	Approximately 19 days	Assessment of treatment emergent adverse events from first study drug intake until follow up

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CRS Clinical-Research-Services Mönchengladbach GmbH; 🇩🇪 Mönchengladbach, Nordrhein-Westfalen, Germany

CRS Clinical Research Services Wuppertal GmbH; 🇩🇪 Wuppertal, Nordrhein-Westfalen, Germany