check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
15171
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Single/multiple dose escalation study in Japanese subjects
Trial purpose
The primary objective
•To investigate the safety and tolerability of BAY 94-8862 after single and multiple oral doses of 10 mg BID, 20 mg BID and 40 mg OD administered as 10 mg IR tablets in Japanese healthy adult male subjects
The secondary objective
•To investigate the pharmacodynamics and pharmacokinetics of BAY 94-8862 in Japanese healthy adult male subjects
•To investigate the safety and tolerability of BAY 94-8862 after single and multiple oral doses of 10 mg BID, 20 mg BID and 40 mg OD administered as 10 mg IR tablets in Japanese healthy adult male subjects
The secondary objective
•To investigate the pharmacodynamics and pharmacokinetics of BAY 94-8862 in Japanese healthy adult male subjects
Key Participants Requirements
Sex
MaleAge
20 - 45 YearsTrial summary
Enrollment Goal
36Trial Dates
February 2012 - July 2012Phase
Phase 1Could I Receive a placebo
YesProducts
Finerenone (BAY94-8862)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kagoshima, 890-0081, Japan |
Primary Outcome
- Cmax: maximum drug concentration in plasma after single dosingdate_rangeTime Frame:Day 1
- Cmax,md: Cmax after multiple dosingdate_rangeTime Frame:Day 1
- AUC: area under the plasma concentration vs time curve from zero to infinity after single (first) dosedate_rangeTime Frame:Day 1
- AUC/D: AUC divided by dose (mg)date_rangeTime Frame:Day 1
- AUCτ,md: AUCτ after multiple dose administrationdate_rangeTime Frame:Day 10
- AUCτ,md/D: AUCτ,md divided by dosedate_rangeTime Frame:Day 10
- Cmax,md: Cmax after multiple dosingdate_rangeTime Frame:Day 10
- Cmax,md/D: Cmax,md divided by dosedate_rangeTime Frame:Day 10
Secondary Outcome
- AUC(0-tlast): AUC from time 0 to the last data pointdate_rangeTime Frame:Day 1
- AUC(0-tlast)/D: AUC(0-tlast) divided by dosedate_rangeTime Frame:Day 1
- AUCnorm: AUC divided by dose per kg body weightdate_rangeTime Frame:Day 1
- Cmax,norm: Cmax divided by dose (mg) per kg body weightdate_rangeTime Frame:Day 1
- t1/2: half-life associated with the terminal slopedate_rangeTime Frame:Day 1
- tmax: time to reach maximum drug concentration in plasma after single dosingdate_rangeTime Frame:Day 1
- MRT: mean residence timedate_rangeTime Frame:Day 1
- CL/F: total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)date_rangeTime Frame:Day 1
- AUCτ,md,norm: AUCτ,md divided by dose (mg) per kg body weightdate_rangeTime Frame:Day 10
- Cmax,md,norm: Cmax,md divided by dose (mg) per kg body weightdate_rangeTime Frame:Day 10
- tmax: time to reach maximum drug concentration in plasma after single dosingdate_rangeTime Frame:Day 10
- t1/2date_rangeTime Frame:Day 10
- MRTdate_rangeTime Frame:Day 10
- CL/fdate_rangeTime Frame:Day 10
- C(24)/Cmax: observed concentration at time 24 hours divided by maximum observed drug concentrationdate_rangeTime Frame:Day 10
- accumulation ratios RACmax (accumulation ratio calculated from Cmax after multiple dosing and Cmax after single dosing)date_rangeTime Frame:Day 10
- RLin: linearity factor of pharmacokinetics after multiple administration of identical doses calculated from AUCt after multiple dosing and AUC after single dosingdate_rangeTime Frame:Day 10
- RAAUC: accumulation ratio calculated from AUCτ after multiple dosing and AUCτ after single dosingdate_rangeTime Frame:Day 10
- AE,ur(0-24): amount excreted into urine from 0 to 24 hoursdate_rangeTime Frame:Day 10
- CLRdate_rangeTime Frame:Day 10
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
2