A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03893787 In Healthy Adult Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-03893787

Study type: Interventional

Funder types: Industry

Identifiers

NCT00992342

B0281003

Details and patient eligibility

About

The purpose of this study is to investigate safety and toleration of multiple oral doses as well as the time course of PF-03893787 concentration in the blood following dosing by oral solution.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects and females of non-childbearing potential between the ages of 18 and 55 years.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

PF-03893787 5 mg

Experimental group

Treatment:

Drug: PF-03893787

Drug: PF-03893787

Drug: PF-03893787

PF-03893787 15 mg

Experimental group

Treatment:

Drug: PF-03893787

Drug: PF-03893787

Drug: PF-03893787

PF-03893787 50 mg

Experimental group

Treatment:

Drug: PF-03893787

Drug: PF-03893787

Drug: PF-03893787