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Trial record 1 of 1 for:    NCT00875628
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A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT00875628
Recruitment Status : Terminated (See Detailed Description)
First Posted : April 3, 2009
Last Update Posted : October 22, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 1, 2009
First Posted Date  ICMJE April 3, 2009
Last Update Posted Date October 22, 2009
Study Start Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2009)
  • Plasma PF-00868554 concentrations [ Time Frame: Day 1-Day 17 ]
  • Urine PF-00868554 concentrations [ Time Frame: Day 1 and Day 14 ]
  • Adverse event monitoring and Physical examination [ Time Frame: Day 0-Day 17 ]
  • ECGs and vital signs (Blood pressure and Pulse rate) [ Time Frame: Day 1-Day 17 ]
  • Clinical safety laboratory tests [ Time Frame: Day 0, Day 7, and Day 17 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00875628 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers
Official Title  ICMJE A Phase 1, Randomized, Double Blind (Sponsor-Open), Placebo Controlled, Dose Escalation, Multiple Dose Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers
Brief Summary Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.
Detailed Description Study A8121018 was prematurely discontinued due to FDA instructions stating that Study A8121018 could not be performed under US IND 78,910, which was provided by the meeting on August 13, 2009. And then the termination was decided by Pfizer on September 8, 2009 prior to subject dosing with PF-00868554. There were no safety concerns regarding the study in the decision to terminate the trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: PF-00868554 or Placebo
    Dosage Form: Oral solution Dosage: PF-00868554 100 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days
  • Drug: PF-00868554 or Placebo
    Dosage Form: Oral solution Dosage: PF-00868554 300 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days
  • Drug: PF-00868554 or Placebo
    Dosage Form: Tablet Dosage: PF-00868554 600 mg or placebo under fed conditions Frequency: BID (twice daily) Duration: 14 days
Study Arms  ICMJE
  • Cohort 1
    PF-00868554 100 mg or placebo
    Intervention: Drug: PF-00868554 or Placebo
  • Cohort 2
    PF-00868554 300 mg or placebo
    Intervention: Drug: PF-00868554 or Placebo
  • Cohort 3
    PF-00868554 600 mg or placebo
    Intervention: Drug: PF-00868554 or 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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 2, 2009)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female Japanese subjects between the ages of 18 and 55 years.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
  • Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
  • Pregnant or nursing females; females of childbearing potential.
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 NCT00875628
Other Study ID Numbers  ICMJE A8121018
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 2009

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