Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.
|ClinicalTrials.gov Identifier: NCT00959803|
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : December 7, 2009
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: PF-04447943 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
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.
- 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) ]
- 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) ]
- Pharmacokinetic (single): AUClast, Cmax, Tmax [ Time Frame: Day 1 to day 5 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959803
|United States, California|
|Pfizer Investigational Site|
|Glendale, California, United States, 91206|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|