Trial Condition(s):

Healthy volunteer

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 Identifier:

18747

ClinicalTrials.gov Identifier:

NCT03252002

EudraCT Number:

2017-001212-11

Recruitment Complete

Trial Purpose

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

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 Summary

Enrollment Goal
96
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
BAY1101042
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical-Research-Services Mönchengladbach GmbH

Mönchengladbach, Germany, 41061

Status
Completed
 
Locations

CRS Clinical Research Services Wuppertal GmbH

Wuppertal, Germany, 42113

Status
Completed
 

Trial Design