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A Study to Investigate the Effect of PH-797804 on QTc Interval

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ClinicalTrials.gov Identifier: NCT01862887
Recruitment Status : Completed
First Posted : May 27, 2013
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 22, 2013
First Posted Date  ICMJE May 27, 2013
Last Update Posted Date August 15, 2013
Study Start Date  ICMJE April 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2013)
QTcF Interval [ Time Frame: -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose ]
QT interval corrected for heart rate using Fredericias correction
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2013)
QTcF Interval [ Time Frame: -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose ]
Change History Complete list of historical versions of study NCT01862887 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2013)
  • QTcI Interval [ Time Frame: -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose ]
    QT interval using individual heart rate correction
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2013)
  • QTcI Interval [ Time Frame: -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose ]
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 the Effect of PH-797804 on QTc Interval
Official Title  ICMJE A Phase 1, Randomized, Placebo-And Positive-Controlled Crossover Study To Determine The Effect Of A Single-Dose Of PH-797804 On QTc Interval In Healthy Volunteers
Brief Summary The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24 mg oral tablet on the QTc interval
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: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PH-797804
    Tablet, 24 mg, single dose
  • Drug: Moxifloxacin
    Tablet, 400 mg, single dose
  • Drug: Placebo
    Tablet, PH-797804 matched placebo, single dose
Study Arms  ICMJE
  • Experimental: PH-797804
    Subjects will receive a single 24 mg dose in the fed state
    Intervention: Drug: PH-797804
  • Experimental: Moxifloxacin
    Subjects will receive a single 400 mg dose in the fed state
    Intervention: Drug: Moxifloxacin
  • Experimental: Placebo
    Subjects will receive a single placebo dose
    Intervention: 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: May 22, 2013)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).

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.
  • History of regular alcohol consumption exceeding 14 drinks/week for males.
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 NCT01862887
Other Study ID Numbers  ICMJE A6631035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2013

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