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Trial record 1 of 1 for:    NCT01098877
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First In Human Study Of Increasing Oral Doses Of PF-04634817

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ClinicalTrials.gov Identifier: NCT01098877
Recruitment Status : Completed
First Posted : April 5, 2010
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 26, 2010
First Posted Date  ICMJE April 5, 2010
Last Update Posted Date October 13, 2010
Study Start Date  ICMJE April 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2010)
  • Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests [ Time Frame: 0-3 days ]
  • Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2 [ Time Frame: 0-4 days ]
  • Urinary pharmacokinetics: Aet (mount excreted in urine), Aet% and CLr [ Time Frame: 0-2 days ]
  • p-ERK inhibition in human monocytes [ Time Frame: 0-3 days ]
  • Change in circulating monocytes [ Time Frame: 0-3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2010)
  • Change from baseline in plasma MCP-1 [ Time Frame: 0-3 days ]
  • MIP 1B stimulated CCR5 receptor internalization [ Time Frame: 0-3 days ]
  • MCP-1 stimulated CCR5 receptor internalization [ Time Frame: 0-3 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First In Human Study Of Increasing Oral Doses Of PF-04634817
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: PF-04634817 Placebo
  • Experimental: Cohort 1, 1mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 1, 3mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 1, 10mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 2, 30mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 2, 100mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 2, 300mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 3, 600mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 3, 900mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 3, up to 900mg (fed)
    Intervention: Drug: PF-04634817
  • Placebo Comparator: Cohort 3, placebo (fed)
    Intervention: Drug: PF-04634817 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2010)
27
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01098877
Other Study ID Numbers  ICMJE B1261002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP