A Phase 1 interventional study of BAY1101042 and Placebo in Healthy Volunteer, sponsored by Bayer. Completed at 2 sites in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-19.
Sponsored by Bayer · Phase 1, Interventional, and Other
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
Exclusion Criteria:
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Drug: BAY1101042 · Drug: 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
Drug: BAY1101042 · Drug: 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
Drug: BAY1101042 · Drug: 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
Drug: BAY1101042 · Drug: 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
Drug: BAY1101042 · Drug: Placebo
Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days
Drug: BAY1101042 · Drug: Placebo
Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)
Number of treatment emergent adverse events (TEAEs)
Assessment of treatment emergent adverse events from first study drug intake until follow up
Time frame: Approximately 19 days
AUC(0-24) of BAY1101042
AUC(0-24): area under the concentration vs. time curve from zero to 24 hours after single dose
Time 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
Time frame: At day 1
Cmax of BAY1101042
Cmax: maximum observed drug concentration after single dose
Time frame: At day 1
Cmax/D of BAY1101042
Cmax/D: dose-normalized maximum observed drug concentration after single dose
Time 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
Time 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
Time frame: At day 9
Cmax,md of BAY1101042
Cmax,md: maximum observed drug concentration after multiple dose
Time frame: At day 9
Cmax,md/D of BAY1101042
Cmax,md/D: dose-normalized maximum observed drug concentration after multiple dose
Time frame: At day 9
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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