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
Overview
- Phase
- Phase 1
- Intervention
- PF-04447943
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- AEs (spontaneous and solicited). Change from baseline in vital signs.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For young cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 18 and 55 years, inclusive.
- •For elderly cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 65 and 85 years, inclusive.
- •Body Mass Index (BMI) between 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs).
Exclusion Criteria
- •Pregnant or nursing women; women of childbearing potential.
- •Males who are unwilling to abstain from sexual intercourse or use a condom with all child-bearing potential women for the duration of the study.
Arms & Interventions
Single dose
3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects.
Intervention: PF-04447943
Single dose
3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects.
Intervention: Placebo
Multiple dose
3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.
Intervention: PF-04447943
Multiple dose
3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.
Intervention: Placebo
Outcomes
Primary Outcomes
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