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Trial record 1 of 1 for:    NCT00989391
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A Study In Healthy People To Investigate The Safety, Toleration And Time Course Of Blood Concentrations Of Multiple Doses Of PF-03654764, Given By Mouth

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: NCT00989391
Recruitment Status : Completed
First Posted : October 5, 2009
Last Update Posted : December 16, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE October 2, 2009
First Posted Date  ICMJE October 5, 2009
Last Update Posted Date December 16, 2009
Study Start Date  ICMJE October 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2009)
safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests, suicidality assessment using the Suicidality Tracking Scale (STS) and physical examination. [ Time Frame: 10 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2009)
safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. [ Time Frame: 10 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2009)
  • Plasma pharmacokinetics: Cmax, Tmax, AUCtau, t½, AUCtau (Day 10)/AUCtau (Day 1), CL/F [ Time Frame: 10 days ]
  • Urine pharmacokinetics: Ae24 & Ae24% (for once daily doses) or Ae12 & Ae12% (for twice daily dose) on Day 10, CLR [ Time Frame: 10 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 A Study In Healthy People To Investigate The Safety, Toleration And Time Course Of Blood Concentrations Of Multiple Doses Of PF-03654764, Given By Mouth
Official Title  ICMJE A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Oral Doses Of PF-03654764 In Healthy Subjects
Brief Summary The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given once or twice daily by mouth for 10 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-03654764
    5mg orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.
  • Drug: placebo
    orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.
  • Drug: PF-03654764
    12mg orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.
  • Drug: PF-03654764
    12mg orally twice daily on Days 1-9, and once on Day 10 After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.
  • Drug: placebo
    oral twice daily on Days 1-9 and once on Day 10. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.
Study Arms  ICMJE
  • Experimental: Cohort 1
    Subjects will be assigned to receive either PF-03654764 or placebo.
    Interventions:
    • Drug: PF-03654764
    • Drug: placebo
  • Experimental: Cohort 2
    Subjects will be assigned to receive either PF-03654764 or placebo.
    Interventions:
    • Drug: PF-03654764
    • Drug: placebo
  • Experimental: Cohort 3
    Subjects will be assigned to receive either PF-03654764 or placebo.
    Interventions:
    • Drug: PF-03654764
    • Drug: 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: October 2, 2009)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • A positive urine drug screen.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 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 Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00989391
Other Study ID Numbers  ICMJE B0711002
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 December 2009

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