ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01098877
Recruitment Status : Completed
First Posted : April 5, 2010
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-04634817 Placebo Drug: PF-04634817 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : April 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests [ Time Frame: 0-3 days ]
  2. Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2 [ Time Frame: 0-4 days ]
  3. Urinary pharmacokinetics: Aet (mount excreted in urine), Aet% and CLr [ Time Frame: 0-2 days ]
  4. p-ERK inhibition in human monocytes [ Time Frame: 0-3 days ]
  5. Change in circulating monocytes [ Time Frame: 0-3 days ]

Secondary Outcome Measures :
  1. Change from baseline in plasma MCP-1 [ Time Frame: 0-3 days ]
  2. MIP 1B stimulated CCR5 receptor internalization [ Time Frame: 0-3 days ]
  3. MCP-1 stimulated CCR5 receptor internalization [ Time Frame: 0-3 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01098877     History of Changes
Other Study ID Numbers: B1261002
First Posted: April 5, 2010    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: October 2010

Keywords provided by Pfizer:
Phase1
pharmacokinetics
safety
toleration
pharmacodynamics