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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: BAY1101042; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
      • CRS Clinical-Research-Services Mönchengladbach GmbH
    • Wuppertal, Nordrhein-Westfalen, Germany, 42113
      • CRS Clinical Research Services Wuppertal GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): July 24, 2019

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Chronic kidney disease
• Other Study ID Numbers: 18747; 2017-001212-11 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No