A Study In Healthy People To Investigate The Safety, Toleration And Time Course Of Blood Concentrations Of Multiple Doses Of PF-03654764, Given By Mouth

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: placebo; Drug: PF-03654764

Study type: Interventional

Funder types: Industry

Identifiers

NCT00989391

B0711002

Details and patient eligibility

About

The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given once or twice daily by mouth for 10 days.

Enrollment: 36 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

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.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

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

Cohort 1

Experimental group

Description:

Subjects will be assigned to receive either PF-03654764 or placebo.

Treatment:

Drug: placebo

Drug: placebo

Drug: PF-03654764

Drug: placebo

Drug: PF-03654764

Drug: PF-03654764

Cohort 2

Experimental group

Description:

Subjects will be assigned to receive either PF-03654764 or placebo.

Treatment:

Drug: placebo

Drug: placebo

Drug: PF-03654764

Drug: placebo

Drug: PF-03654764

Drug: PF-03654764

Cohort 3

Experimental group

Description:

Subjects will be assigned to receive either PF-03654764 or placebo.

Treatment:

Drug: placebo

Drug: placebo

Drug: PF-03654764

Drug: placebo

Drug: PF-03654764

Drug: PF-03654764