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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02170012

Enrollment

Registered

2014-06-23

Start date

2014-07-31

Completion date

2014-09-30

Last updated

2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Elderly

Keywords

Multiple dose, safety, tolerability, PK

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.

Interventions

DRUGPF-06743649

20 mg tablet once daily dosing for 14 days

DRUGPlacebo

Placebo tablet once daily dosing for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to 85 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Renal clearance (CLr)	up to 14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)	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
Percent of dose recovered unchanged in urine during the dosing interval(Aetau%)	up to 14 days
Maximum Observed Plasma Concentration (Cmax)	up to 14 days

Secondary

Measure	Time frame
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
Urinary hypoxanthine levels	up to 14 days
Change from baseline in serum uric acid level	up to 14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026