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Trial record 1 of 1 for:    NCT02151617
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A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649

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ClinicalTrials.gov Identifier: NCT02151617
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 28, 2014
First Posted Date  ICMJE May 30, 2014
Last Update Posted Date January 19, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: up to 14 days ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: up to 14 days ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: up to 14 days ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: up to 14 days ]
  • Amount of drug recovered unchanged in urine during the dosing interval (Aetau) [ Time Frame: up to 14 days ]
  • Percent of dose recovered unchanged in urine during the dosing interval(Aetau%) [ Time Frame: up to 14 days ]
  • Renal clearance (CLr) [ Time Frame: up to 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • Change from baseline in serum uric acid level [ Time Frame: up to 14 days ]
  • Change from baseline in serum levels of xanthine and hypoxanthine [ Time Frame: up to 14 days ]
  • Urinary uric acid levels [ Time Frame: up to 14 days ]
  • Urinary xanthine levels [ Time Frame: up to 14 days ]
  • Urinary hypoxanthine levels [ Time Frame: up to 14 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 Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649
Official Title  ICMJE A Phase 1 Double Blind (3rd Party Open) Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety,Tolerability, Pharmacokinetics And Pharmacodynamics Of Repeat Doses Of Pf-06743649 With Or Without Food In Healthy Adult Subjects
Brief Summary The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649. The pharmacodynamic activity of PF-06743649 will also be assessed. The effect of food on PK of PF-06743649 will also be investigated.
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-06743649
    40 mg tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
  • Drug: Placebo
    Placebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
  • Drug: PF-06743649
    To be decided dose, tablet once daily dosing for 14 days
  • Drug: Placebo
    Placebo tablet once daily dosing for 14 days
  • Drug: PF-06743649
    To be decided dose, tablet, one time once with a meal and once without a meal, followed by once daily dosing for 14 days
  • Drug: PF-06743649
    To be decided dose, tablet, one time without a meal, followed by once daily dosing for 14 days
  • Drug: Placebo
    Placebo tablet one time once without a meal, followed by once daily dosing for 14 days
  • Drug: PF-06743649
    Tablet, to be decided dose, once daily, 14 days
  • Drug: Placebo
    Tablet, once daily, 14 days
Study Arms  ICMJE
  • Experimental: Cohort 1-PF-06743649 or placebo
    Subjects will be randomized to receive PF-06743649 or placebo as 2 single doses in periods 1 and 2 either in the fed or fasted state followed by once daily dosing for 14 days in period 3
    Interventions:
    • Drug: PF-06743649
    • Drug: Placebo
  • Experimental: Cohort 2-PF-06743649 or placebo
    Interventions:
    • Drug: PF-06743649
    • Drug: Placebo
  • Experimental: Cohort 3-PF-06743649 or placebo
    Interventions:
    • Drug: PF-06743649
    • Drug: Placebo
  • Experimental: Cohort 4-PF-06743649 or placebo
    Interventions:
    • Drug: PF-06743649
    • Drug: Placebo
  • Experimental: Cohort 5-PF-06743649 or placebo
    Interventions:
    • Drug: PF-06743649
    • 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: December 19, 2014)
40
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2014)
50
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects 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 measurement, 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).
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

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).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • Evidence of gout/hyperuricemia, measured sUA >8 mg/dL at screening.
  • Experienced an episode of nephrolithiasis or ureterolithiasis.
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 NCT02151617
Other Study ID Numbers  ICMJE B7911001
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 January 2015

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