A Study In Healthy 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 With Or Without Food In Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02151617

Enrollment

Registered

2014-05-30

Start date

2014-06-30

Completion date

2014-12-31

Last updated

2015-01-19

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

Conditions

Healthy

Keywords

Multiple dose, safety, tolerability, PK

Brief summary

The purpose of this study in healthy 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. The effect of food on PK of PF-06743649 will also be investigated.

Interventions

DRUGPF-06743649

40 mg tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days

DRUGPlacebo

Placebo tablet one time once with a meal and once without a meal, followed by 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

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). * 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