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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-04634817; Drug: PF-04634817 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01098877

B1261002

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female (of non-child bearing potential) subjects between 18 and 55 years of age.
• Body mass index of 17.5 to 30.5 kg/m2 and total body weight > 50kg.

Exclusion criteria

• Evidence or history of any clinically significant disease.
• Treatment with an investigational drug within 30 days of study start
• Use of prescription and non-prescription medicines within 7 days of study start

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 participants in 11 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: PF-04634817 Placebo

Drug: PF-04634817 Placebo

Cohort 1, 1mg

Experimental group

Treatment:

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Cohort 1, 3mg

Experimental group

Treatment:

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Cohort 1, 10mg

Experimental group

Treatment:

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Cohort 2, 30mg

Experimental group

Treatment:

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Cohort 2, 100mg

Experimental group

Treatment:

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Cohort 2, 300mg

Experimental group

Treatment:

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Cohort 3, 600mg

Experimental group

Treatment:

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Cohort 3, 900mg

Experimental group

Treatment:

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Cohort 3, up to 900mg (fed)

Experimental group

Treatment:

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Drug: PF-04634817

Cohort 3, placebo (fed)

Placebo Comparator group

Treatment:

Drug: PF-04634817 Placebo

Drug: PF-04634817 Placebo