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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252002
• Other study ID #: 18747
• Secondary ID: 2017-001212-11
• Status: Completed
• Phase: Phase 1
• Start date: August 16, 2017
• Est. completion date: July 24, 2019

Study information

• Verified date: August 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 24, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

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
• Placebo
Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)

Locations

Country	Name	City	State
Germany	CRS Clinical-Research-Services Mönchengladbach GmbH	Mönchengladbach	Nordrhein-Westfalen
Germany	CRS Clinical Research Services Wuppertal GmbH	Wuppertal	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Cmax of BAY1101042	Cmax: maximum observed drug concentration after single dose	At day 1
Secondary	Cmax/D of BAY1101042	Cmax/D: dose-normalized maximum observed drug concentration after single dose	At day 1
Secondary	AUCt,md of BAY1101042	AUCt,md: area under the concentration vs. time curve for the actual dosing interval after multiple dose	At day 9
Secondary	AUCt,md/D of BAY1101042	AUCt,md/D: dose-normalized area under the concentration vs. time curve for the actual dosing interval after multiple dose	At day 9
Secondary	Cmax,md of BAY1101042	Cmax,md: maximum observed drug concentration after multiple dose	At day 9
Secondary	Cmax,md/D of BAY1101042	Cmax,md/D: dose-normalized maximum observed drug concentration after multiple dose	At day 9