A Double Blind, 3rd Party Open, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- PF-04531083 or Placebo
- Conditions
- Healthy Volunteers
- Sponsor
- Pfizer
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male and/or female subjects btween the ages of 18-55 years
- •Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).
Exclusion Criteria
- •Evidence or history of clinically signifcant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •A positive urine drug screen.
- •History of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening
- •Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
- •Pregnant or nursing females; females of childbearing potentioal who are unwilling or unable to use an acceptable method on contraception.
Arms & Interventions
Cohort 1
Intervention: PF-04531083 or Placebo
Cohort 2
Intervention: PF-04531083 or Placebo
Cohort 3
Intervention: PF-04531083 or Placebo
Cohort 4
Intervention: PF-04531083 or Placebo
Outcomes
Primary Outcomes
Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index
Time Frame: days 1-15
Safety of subjects following multiple dosing of PF-04531083 (adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood and urine safety tests)
Time Frame: days 1-15
Secondary Outcomes
- pharmacokinetics of alternative formulations(days 1-15)