Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PF-04531083 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012310

B1351002

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups

Cohort 1

Experimental group

Treatment:

Drug: PF-04531083 or Placebo

Drug: PF-04531083 or Placebo

Drug: PF-04531083 or Placebo

Drug: PF-04531083 or Placebo

Cohort 2

Experimental group

Treatment:

Drug: PF-04531083 or Placebo

Drug: PF-04531083 or Placebo

Drug: PF-04531083 or Placebo

Drug: PF-04531083 or Placebo

Cohort 3

Experimental group

Treatment:

Drug: PF-04531083 or Placebo

Drug: PF-04531083 or Placebo

Drug: PF-04531083 or Placebo

Drug: PF-04531083 or Placebo

Cohort 4

Experimental group

Treatment:

Drug: PF-04531083 or Placebo

Drug: PF-04531083 or Placebo

Drug: PF-04531083 or Placebo

Drug: PF-04531083 or Placebo