Status:
COMPLETED
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects
Lead Sponsor:
Bayer
Conditions:
Healthy Volunteer
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2019
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03252002
Start Date
August 16 2017
End Date
July 24 2019
Last Update
August 19 2019
Active Locations (2)
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1
CRS Clinical-Research-Services Mönchengladbach GmbH
Mönchengladbach, North Rhine-Westphalia, Germany, 41061
2
CRS Clinical Research Services Wuppertal GmbH
Wuppertal, North Rhine-Westphalia, Germany, 42113