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

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Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: PF-04634817 Placebo
Drug: PF-04634817

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

27 participants in 11 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: PF-04634817 Placebo
Cohort 1, 1mg
Experimental group
Treatment:
Drug: PF-04634817
Cohort 1, 3mg
Experimental group
Treatment:
Drug: PF-04634817
Cohort 1, 10mg
Experimental group
Treatment:
Drug: PF-04634817
Cohort 2, 30mg
Experimental group
Treatment:
Drug: PF-04634817
Cohort 2, 100mg
Experimental group
Treatment:
Drug: PF-04634817
Cohort 2, 300mg
Experimental group
Treatment:
Drug: PF-04634817
Cohort 3, 600mg
Experimental group
Treatment:
Drug: PF-04634817
Cohort 3, 900mg
Experimental group
Treatment:
Drug: PF-04634817
Cohort 3, up to 900mg (fed)
Experimental group
Treatment:
Drug: PF-04634817
Cohort 3, placebo (fed)
Placebo Comparator group
Treatment:
Drug: PF-04634817 Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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