do_not_disturb_altRecruitment Complete

Healthy volunteer

Bayer Identifier:

18747

ClinicalTrials.gov Identifier:

NCT03252002

EudraCT Number:

2017-001212-11

EU CT Number:

Not Available
Clinical study to evaluate the pharmacokinetics, safety, tolerability and pharmacodynamic effects of a single and multiple oral BAY1101042 tablet doses in healthy male subjects

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

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - 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.


  • - 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
August 2017 - July 2019
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY1101042
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Mönchengladbach GmbHMönchengladbach, 41061, Germany
Completed
CRS Clinical Research Services Wuppertal GmbHWuppertal, 42113, Germany

Primary Outcome

  • Number of treatment emergent adverse events (TEAEs)
    Assessment of treatment emergent adverse events from first study drug intake until follow up
    date_rangeTime Frame:
    Approximately 19 days

Secondary Outcome

  • AUC(0-24) of BAY1101042
    AUC(0-24): area under the concentration vs. time curve from zero to 24 hours after single dose
    date_rangeTime Frame:
    At day 1
  • AUC(0-24)/D of BAY1101042
    AUC(0-24)/D: dose-normalized area under the concentration vs. time curve from zero to 24 hours after single dose
    date_rangeTime Frame:
    At day 1
  • Cmax of BAY1101042
    Cmax: maximum observed drug concentration after single dose
    date_rangeTime Frame:
    At day 1
  • Cmax/D of BAY1101042
    Cmax/D: dose-normalized maximum observed drug concentration after single dose
    date_rangeTime Frame:
    At day 1
  • AUCτ,md of BAY1101042
    AUCτ,md: area under the concentration vs. time curve for the actual dosing interval after multiple dose
    date_rangeTime Frame:
    At day 9
  • AUCτ,md/D of BAY1101042
    AUCτ,md/D: dose-normalized area under the concentration vs. time curve for the actual dosing interval after multiple dose
    date_rangeTime Frame:
    At day 9
  • Cmax,md of BAY1101042
    Cmax,md: maximum observed drug concentration after multiple dose
    date_rangeTime Frame:
    At day 9
  • Cmax,md/D of BAY1101042
    Cmax,md/D: dose-normalized maximum observed drug concentration after multiple dose
    date_rangeTime Frame:
    At day 9

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