A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: PF-04418948

Study type

Interventional

Funder types

Industry

Identifiers

NCT01002963

B0631001

Details and patient eligibility

About

The purpose of this study is to investigate safety and toleration of single oral doses as well as the time course of PF-04418948 concentration in the blood following dosing by oral solution.

Enrollment

56 estimated patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 7 patient groups

PF-04418948 30 mg

Experimental group

Treatment:

Drug: PF-04418948

PF-04418948 100 mg

Experimental group

Treatment:

Drug: PF-04418948

PF-04418948 300 mg

Experimental group

Treatment:

Drug: PF-04418948

PF-04418948 1000 mg

Experimental group

Treatment:

Drug: PF-04418948

PF-04418948 3000 mg

Experimental group

Treatment:

Drug: PF-04418948

PF-04418948 4500 mg

Experimental group

Treatment:

Drug: PF-04418948

PF-04418948 6000 mg

Experimental group

Treatment:

Drug: PF-04418948

Trial contacts and locations

1

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