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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations CRS Clinical-Research-Services Mönchengladbach GmbH Mönchengladbach, Germany, 41061 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CRS Clinical Research Services Wuppertal GmbH Wuppertal, Germany, 42113 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
6
Primary Outcome
- Number of treatment emergent adverse events (TEAEs)Assessment of treatment emergent adverse events from first study drug intake until follow upTimeframe: Approximately 19 days
Secondary Outcome
- AUC(0-24) of BAY1101042AUC(0-24): area under the concentration vs. time curve from zero to 24 hours after single doseTimeframe: At day 1
- AUC(0-24)/D of BAY1101042AUC(0-24)/D: dose-normalized area under the concentration vs. time curve from zero to 24 hours after single doseTimeframe: At day 1
- Cmax of BAY1101042Cmax: maximum observed drug concentration after single doseTimeframe: At day 1
- Cmax/D of BAY1101042Cmax/D: dose-normalized maximum observed drug concentration after single doseTimeframe: At day 1
- AUCτ,md of BAY1101042AUCτ,md: area under the concentration vs. time curve for the actual dosing interval after multiple doseTimeframe: At day 9
- AUCτ,md/D of BAY1101042AUCτ,md/D: dose-normalized area under the concentration vs. time curve for the actual dosing interval after multiple doseTimeframe: At day 9
- Cmax,md of BAY1101042Cmax,md: maximum observed drug concentration after multiple doseTimeframe: At day 9
- Cmax,md/D of BAY1101042Cmax,md/D: dose-normalized maximum observed drug concentration after multiple doseTimeframe: At day 9
Additional Information
Not Available
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