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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01098877
First received: March 26, 2010
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: PF-04634817 Placebo
Drug: PF-04634817
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Pharmacokinetics (In The Fed And Fasted State), Safety And Toleration Of Single Oral Doses Of PF-04634817 In Healthy Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests [ Time Frame: 0-3 days ] [ Designated as safety issue: Yes ]
  • Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2 [ Time Frame: 0-4 days ] [ Designated as safety issue: No ]
  • Urinary pharmacokinetics: Aet (mount excreted in urine), Aet% and CLr [ Time Frame: 0-2 days ] [ Designated as safety issue: No ]
  • p-ERK inhibition in human monocytes [ Time Frame: 0-3 days ] [ Designated as safety issue: No ]
  • Change in circulating monocytes [ Time Frame: 0-3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in plasma MCP-1 [ Time Frame: 0-3 days ] [ Designated as safety issue: No ]
  • MIP 1B stimulated CCR5 receptor internalization [ Time Frame: 0-3 days ] [ Designated as safety issue: No ]
  • MCP-1 stimulated CCR5 receptor internalization [ Time Frame: 0-3 days ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: PF-04634817 Placebo
Oral solution, placebo, single dose
Experimental: Cohort 1, 1mg Drug: PF-04634817
Oral solution, 1mg, single dose
Experimental: Cohort 1, 3mg Drug: PF-04634817
Oral solution, 3mg, single dose
Experimental: Cohort 1, 10mg Drug: PF-04634817
Oral solution, 10mg, single dose
Experimental: Cohort 2, 30mg Drug: PF-04634817
Oral solution, 30mg, single dose
Experimental: Cohort 2, 100mg Drug: PF-04634817
Oral solution, 100mg, single dose
Experimental: Cohort 2, 300mg Drug: PF-04634817
Oral solution, 300mg, single dose
Experimental: Cohort 3, 600mg Drug: PF-04634817
Oral solution, 600mg, single dose
Experimental: Cohort 3, 900mg Drug: PF-04634817
Oral solution, 900mg, single dose
Experimental: Cohort 3, up to 900mg (fed) Drug: PF-04634817
Oral solution, up to 900mg, single dose after food
Placebo Comparator: Cohort 3, placebo (fed) Drug: PF-04634817 Placebo
Oral solution, placebo, single dose after food

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098877

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01098877     History of Changes
Other Study ID Numbers: B1261002
Study First Received: March 26, 2010
Last Updated: October 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase1
pharmacokinetics
safety
toleration
pharmacodynamics

ClinicalTrials.gov processed this record on August 28, 2014