Clinical trial NCT02170012: A Study In Healthy Elderly People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses Of PF-06743649
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Elderly
Keywords: Multiple dose
safety
tolerability
PK
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: up to 14 days
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
timeFrame: up to 14 days
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: up to 14 days
measure: Plasma Decay Half-Life (t1/2)
timeFrame: up to 14 days
measure: Amount of drug recovered unchanged in urine during the dosing interval (Aetau)
timeFrame: up to 14 days
measure: Percent of dose recovered unchanged in urine during the dosing interval(Aetau%)
timeFrame: up to 14 days
measure: Renal clearance (CLr)
timeFrame: up to 14 days
Secondary outcomes:
measure: Change from baseline in serum uric acid level
timeFrame: up to 14 days
measure: Change from baseline in serum levels of xanthine and hypoxanthine
timeFrame: up to 14 days
measure: Urinary uric acid levels
timeFrame: up to 14 days
measure: Urinary xanthine levels
timeFrame: up to 14 days
measure: Urinary hypoxanthine levels
timeFrame: up to 14 days
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Miami Research Associates, Inc.
state: Florida
city: South Miami
country: United States
facility: MRA Clinical Research, LLC
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: