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

Bayer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: BAY1101042

Study type: Interventional

Funder types: Industry

Identifiers

NCT03252002

18747

2017-001212-11 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 6 patient groups

Single/multiple doses of 10 mg BAY1101042 or placebo

Experimental group

Description:

Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days

Treatment:

Drug: BAY1101042

Drug: Placebo

Single/ multiple doses of 20 mg BAY1101042 or placebo

Experimental group

Description:

Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days

Treatment:

Drug: BAY1101042

Drug: Placebo

Single/ multiple doses of 30 mg BAY1101042 or placebo

Experimental group

Description:

Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days

Treatment:

Drug: BAY1101042

Drug: Placebo

Single/ multiple doses of 40 mg BAY1101042 or placebo

Experimental group

Description:

Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days

Treatment:

Drug: BAY1101042

Drug: Placebo

Single/ multiple doses of 50 mg BAY1101042 or placebo

Experimental group

Description:

Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days

Treatment:

Drug: BAY1101042

Drug: Placebo

Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo

Experimental group

Description:

Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days

Treatment:

Drug: BAY1101042

Drug: Placebo