Trial Condition(s):
Clinical Pharmacology
Single/multiple dose escalation study in Japanese subjects
Bayer Identifier:
15171
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Inclusion Criteria
- Japanese healthy adult male subjects, 20 to 45 years of age, with body mass index between 17.6 to 26.4 kg/m^2 inclusive
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Kagoshima, Japan, 890-0081 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
A single-center, randomized, single-blinded, placebo-controlled, group-comparison, combined single/multiple dose escalation study to investigate the safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 94-8862 in Japanese healthy adult male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Sequential Assignment
Trial Arms:
2
Primary Outcome
- Cmax: maximum drug concentration in plasma after single dosingTimeframe: Day 1
- Cmax,md: Cmax after multiple dosingTimeframe: Day 1
- AUC: area under the plasma concentration vs time curve from zero to infinity after single (first) doseTimeframe: Day 1
- AUC/D: AUC divided by dose (mg)Timeframe: Day 1
- AUCτ,md: AUCτ after multiple dose administrationTimeframe: Day 10
- AUCτ,md/D: AUCτ,md divided by doseTimeframe: Day 10
- Cmax,md: Cmax after multiple dosingTimeframe: Day 10
- Cmax,md/D: Cmax,md divided by doseTimeframe: Day 10
Secondary Outcome
- AUC(0-tlast): AUC from time 0 to the last data pointTimeframe: Day 1
- AUC(0-tlast)/D: AUC(0-tlast) divided by doseTimeframe: Day 1
- AUCnorm: AUC divided by dose per kg body weightTimeframe: Day 1
- Cmax,norm: Cmax divided by dose (mg) per kg body weightTimeframe: Day 1
- t1/2: half-life associated with the terminal slopeTimeframe: Day 1
- tmax: time to reach maximum drug concentration in plasma after single dosingTimeframe: Day 1
- MRT: mean residence timeTimeframe: Day 1
- CL/F: total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)Timeframe: Day 1
- AUCτ,md,norm: AUCτ,md divided by dose (mg) per kg body weightTimeframe: Day 10
- Cmax,md,norm: Cmax,md divided by dose (mg) per kg body weightTimeframe: Day 10
- tmax: time to reach maximum drug concentration in plasma after single dosingTimeframe: Day 10
- t1/2Timeframe: Day 10
- MRTTimeframe: Day 10
- CL/fTimeframe: Day 10
- C(24)/Cmax: observed concentration at time 24 hours divided by maximum observed drug concentrationTimeframe: Day 10
- accumulation ratios RACmax (accumulation ratio calculated from Cmax after multiple dosing and Cmax after single dosing)Timeframe: Day 10
- RLin: linearity factor of pharmacokinetics after multiple administration of identical doses calculated from AUCt after multiple dosing and AUC after single dosingTimeframe: Day 10
- RAAUC: accumulation ratio calculated from AUCτ after multiple dosing and AUCτ after single dosingTimeframe: Day 10
- AE,ur(0-24): amount excreted into urine from 0 to 24 hoursTimeframe: Day 10
- CLRTimeframe: Day 10
Additional Information
Not Available
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