TerminatedNCT02170012Updated Mar 17, 2015

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

A Phase 1 interventional study of PF-06743649 and Placebo in Healthy Elderly, sponsored by Pfizer. Terminated at 2 sites in United States. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-17.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Why this study was terminated

The study was prematurely terminated on 17th December 2014 due to safety concerns.

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 65 Years to 85 Years
Sex: All

Study 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.

Conditions studied

Healthy Elderly

Keywords

Multiple dose
safety
tolerability
PK

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 65 Years to 85 Years
Sexes eligible: All
Accepts 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

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

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 24 participants (actual)

Study arms

Experimental
Cohort 1-PF-06743649 or placebo
Drug: PF-06743649 · Drug: Placebo
Experimental
Cohort 2-PF-06743649 or placebo
Drug: PF-06743649 · Drug: Placebo
Experimental
Cohort 3-PF-06743649 or placebo
Drug: PF-06743649 · Drug: Placebo
Experimental
Cohort 4-PF-06743649 or placebo
Drug: PF-06743649 · Drug: Placebo
Experimental
Cohort 5-PF-06743649 or placebo
Drug: PF-06743649 · Drug: Placebo

Interventions

DrugPF-06743649
20 mg tablet once daily dosing for 14 days
DrugPlacebo
Placebo tablet once daily dosing for 14 days
DrugPF-06743649
To be decided dose, tablet once daily dosing for 14 days
DrugPlacebo
Placebo tablet once daily dosing for 14 days
DrugPF-06743649
To be decided dose, tablet once daily dosing for 14 days
DrugPlacebo
Placebo tablet once daily dosing for 14 days
DrugPF-06743649
To be decided dose, tablet once daily dosing for 14 days
DrugPlacebo
Placebo tablet once daily dosing for 14 days
DrugPF-06743649
To be decided dose, tablet once daily dosing for 14 days
DrugPlacebo
Placebo tablet once daily dosing for 14 days

What researchers measure

Primary outcomes

Maximum Observed Plasma Concentration (Cmax)
Time frame: up to 14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time frame: up to 14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: up to 14 days
Plasma Decay Half-Life (t1/2)
Time frame: up to 14 days
Amount of drug recovered unchanged in urine during the dosing interval (Aetau)
Time frame: up to 14 days
Percent of dose recovered unchanged in urine during the dosing interval(Aetau%)
Time frame: up to 14 days
Renal clearance (CLr)
Time frame: up to 14 days

Secondary outcomes

Change from baseline in serum uric acid level
Time frame: up to 14 days
Change from baseline in serum levels of xanthine and hypoxanthine
Time frame: up to 14 days
Urinary uric acid levels
Time frame: up to 14 days
Urinary xanthine levels
Time frame: up to 14 days
Urinary hypoxanthine levels
Time frame: up to 14 days

Study locations

2 sites

Miami Research Associates, Inc.
South Miami, Florida 33143, United States
MRA Clinical Research, LLC
South Miami, Florida 33143, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02170012
Lead sponsor: Pfizer
Responsible party: Sponsor
First posted: Jun 23, 2014
Start date: Jul 2014
Primary completion: Sep 2014
Completion: Sep 2014
Last update: Mar 17, 2015

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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