A Study In Healthy Elderly People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses Of PF-06743649
- Registration Number
- NCT02170012
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3-PF-06743649 or placebo PF-06743649 - Cohort 1-PF-06743649 or placebo PF-06743649 - Cohort 4-PF-06743649 or placebo PF-06743649 - Cohort 4-PF-06743649 or placebo Placebo - Cohort 1-PF-06743649 or placebo Placebo - Cohort 2-PF-06743649 or placebo PF-06743649 - Cohort 3-PF-06743649 or placebo Placebo - Cohort 5-PF-06743649 or placebo Placebo - Cohort 2-PF-06743649 or placebo Placebo - Cohort 5-PF-06743649 or placebo PF-06743649 -
- Primary Outcome Measures
Name Time Method Plasma Decay Half-Life (t1/2) up to 14 days Renal clearance (CLr) up to 14 days Maximum Observed Plasma Concentration (Cmax) up to 14 days Percent of dose recovered unchanged in urine during the dosing interval(Aetau%) up to 14 days Time to Reach Maximum Observed Plasma Concentration (Tmax) up to 14 days Area Under the Curve from Time Zero to end of dosing interval (AUCtau) up to 14 days Amount of drug recovered unchanged in urine during the dosing interval (Aetau) up to 14 days
- Secondary Outcome Measures
Name Time Method Urinary uric acid levels up to 14 days Change from baseline in serum uric acid level up to 14 days Change from baseline in serum levels of xanthine and hypoxanthine up to 14 days Urinary xanthine levels up to 14 days Urinary hypoxanthine levels up to 14 days
Trial Locations
- Locations (2)
MRA Clinical Research, LLC
🇺🇸South Miami, Florida, United States
Miami Research Associates, Inc.
🇺🇸South Miami, Florida, United States