A Study In Healthy Elderly People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses Of PF-06743649

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Healthy Elderly

Treatments: Drug: PF-06743649; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02170012

B7911004

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 5 patient groups

Cohort 1-PF-06743649 or placebo

Experimental group

Treatment:

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Cohort 2-PF-06743649 or placebo

Experimental group

Treatment:

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Cohort 3-PF-06743649 or placebo

Experimental group

Treatment:

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Cohort 4-PF-06743649 or placebo

Experimental group

Treatment:

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Cohort 5-PF-06743649 or placebo

Experimental group

Treatment:

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: PF-06743649

Drug: Placebo

Drug: Placebo