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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Volunteer
- Sponsor
- Bayer
- Enrollment
- 96
- Locations
- 2
- Primary Endpoint
- Number of treatment emergent adverse events (TEAEs)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility Criteria
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/m
- •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).
Arms & Interventions
Single/ multiple doses of 40 mg BAY1101042 or placebo
Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Intervention: Placebo
Single/multiple doses of 10 mg BAY1101042 or placebo
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Intervention: BAY1101042
Single/multiple doses of 10 mg BAY1101042 or placebo
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Intervention: Placebo
Single/ multiple doses of 20 mg BAY1101042 or placebo
Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Intervention: BAY1101042
Single/ multiple doses of 20 mg BAY1101042 or placebo
Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Intervention: Placebo
Single/ multiple doses of 30 mg BAY1101042 or placebo
Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Intervention: BAY1101042
Single/ multiple doses of 30 mg BAY1101042 or placebo
Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Intervention: Placebo
Single/ multiple doses of 40 mg BAY1101042 or placebo
Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Intervention: BAY1101042
Single/ multiple doses of 50 mg BAY1101042 or placebo
Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Intervention: BAY1101042
Single/ multiple doses of 50 mg BAY1101042 or placebo
Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Intervention: Placebo
Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo
Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days
Intervention: BAY1101042
Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo
Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days
Intervention: Placebo
Outcomes
Primary Outcomes
Number of treatment emergent adverse events (TEAEs)
Time Frame: Approximately 19 days
Assessment of treatment emergent adverse events from first study drug intake until follow up
Secondary Outcomes
- Cmax,md/D of BAY1101042(At day 9)
- AUC(0-24) of BAY1101042(At day 1)
- Cmax/D of BAY1101042(At day 1)
- AUCτ,md of BAY1101042(At day 9)
- Cmax,md of BAY1101042(At day 9)
- AUCτ,md/D of BAY1101042(At day 9)
- AUC(0-24)/D of BAY1101042(At day 1)
- Cmax of BAY1101042(At day 1)