First In Human Study Of Increasing Oral Doses Of PF-04634817

Summary

The study will evaluate the hypothesis that at doses and plasma concentrations which affect pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic profile is robust and consistent with a once or twice a day therapeutic administration.

Conditions

• Healthy

Interventions

DRUG

PF-04634817 Placebo

Oral solution, placebo, single dose

DRUG

PF-04634817

Oral solution, 1mg, single dose

DRUG

PF-04634817

Oral solution, 3mg, single dose

DRUG

PF-04634817

Oral solution, 10mg, single dose

DRUG

PF-04634817

Oral solution, 30mg, single dose

DRUG

PF-04634817

Oral solution, 100mg, single dose

DRUG

PF-04634817

Oral solution, 300mg, single dose

DRUG

PF-04634817

Oral solution, 600mg, single dose

DRUG

PF-04634817

Oral solution, 900mg, single dose

DRUG

PF-04634817

Oral solution, up to 900mg, single dose after food

DRUG

PF-04634817 Placebo

Oral solution, placebo, single dose after food

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-04-30

Primary Completion

2010-09-30

Completion

2010-09-30

Countries

• United States

Study Locations