Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.
This study is designed to investigate the safety, tolerability, and pharmacokinetics of PF-04447943 after single and multiple-dose administration to healthy young adult and elderly Japanese subjects, respectively.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||An Investigator- And Subject-Blind Phase 1 Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04447943 After Administration Of Single Oral Doses To Healthy Young Adult Japanese Subjects And Multiple Oral Doses To Healthy Elderly Japanese Subjects|
- AEs (spontaneous and solicited). Change from baseline in vital signs. [ Time Frame: Day 0 to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm) ] [ Designated as safety issue: Yes ]
- ECG and clinical safety laboratory endpoints, including a complete blood count, a full chemistry panel (including electrolytes and hepatic transaminases) and urinalysis. [ Time Frame: Screening visit to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm) ] [ Designated as safety issue: Yes ]
- Pharmacokinetic (single): AUClast, Cmax, Tmax [ Time Frame: Day 1 to day 5 ] [ Designated as safety issue: No ]
- Pharmacokinetic(multiple): AUCt, Cmax and Tmax on Days 1 and 7, and Ctrough on Days 2, 3, 4 and 7. [ Time Frame: Day 1 to day 11 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Experimental: Single dose
3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects.
3 mg solution, oral single dose.Drug: PF-04447943
10 mg solution, oral single dose.Drug: PF-04447943
25 mg solution, oral single dose.Drug: Placebo
Solution, oral single dose.
Experimental: Multiple dose
3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.
25 mg solution, oral twice daily for 7 days.Drug: Placebo
Solution, oral twice daily for 7 days.