A Study In Healthy Elderly People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses Of PF-06743649
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Healthy Elderly
In brief
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.
Key facts
- Study ID
- NCT02170012
- Run by
- Pfizer
- People needed
- 24
- Starts
- 2014-07-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2015-03-17
Who can join
Age: 65 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Miami Research Associates, Inc. — South Miami, Florida, United States
- MRA Clinical Research, LLC — South Miami, Florida, United States
Full record on ClinicalTrials.gov
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