A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649
- Registration Number
- NCT02151617
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 4-PF-06743649 or placebo Placebo - Cohort 3-PF-06743649 or placebo PF-06743649 - Cohort 1-PF-06743649 or placebo PF-06743649 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 Cohort 2-PF-06743649 or placebo Placebo - Cohort 5-PF-06743649 or placebo PF-06743649 - Cohort 1-PF-06743649 or placebo 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 Cohort 2-PF-06743649 or placebo PF-06743649 - Cohort 3-PF-06743649 or placebo Placebo - Cohort 4-PF-06743649 or placebo PF-06743649 - Cohort 5-PF-06743649 or placebo Placebo -
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) up to 14 days Time to Reach Maximum Observed Plasma Concentration (Tmax) up to 14 days Plasma Decay Half-Life (t1/2) up to 14 days Amount of drug recovered unchanged in urine during the dosing interval (Aetau) up to 14 days Area Under the Curve from Time Zero to end of dosing interval (AUCtau) up to 14 days Renal clearance (CLr) up to 14 days Percent of dose recovered unchanged in urine during the dosing interval(Aetau%) up to 14 days
- Secondary Outcome Measures
Name Time Method Change from baseline in serum uric acid level up to 14 days Urinary hypoxanthine levels up to 14 days Change from baseline in serum levels of xanthine and hypoxanthine up to 14 days Urinary uric acid levels up to 14 days Urinary xanthine levels up to 14 days
Trial Locations
- Locations (1)
New Haven Clinical Research Unit
🇺🇸New Haven, Connecticut, United States