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Trial record 1 of 1 for:    NCT02170012
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A Study In Healthy Elderly People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses Of PF-06743649

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ClinicalTrials.gov Identifier: NCT02170012
Recruitment Status : Terminated (The study was prematurely terminated on 17th December 2014 due to safety concerns.)
First Posted : June 23, 2014
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 19, 2014
First Posted Date  ICMJE June 23, 2014
Last Update Posted Date March 17, 2015
Study Start Date  ICMJE July 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 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 Complete list of historical versions of study NCT02170012 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 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 Elderly 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 In Healthy Elderly Subjects
Brief Summary The purpose of this study in healthy elderly 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.
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 Elderly
Intervention  ICMJE
  • Drug: PF-06743649
    20 mg 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 once daily dosing for 14 days
Study Arms  ICMJE
  • Experimental: Cohort 1-PF-06743649 or placebo
    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 Terminated
Actual Enrollment  ICMJE
 (submitted: February 10, 2015)
24
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2014)
60
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 65 and 85 years, inclusive. Ideally at least 25% of the subjects enrolled in each cohort will be 75 years of age and above at Screening. Subjects must be healthy as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12-lead ECG and clinical laboratory test results. Subjects with mild, chronic, stable disease and on stable medication may be enrolled if deemed medically prudent by the investigator.
  • 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 65 Years to 85 Years   (Older 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 NCT02170012
Other Study ID Numbers  ICMJE B7911004
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 March 2015

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