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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: PF-06743649

Study type: Interventional

Funder types: Industry

Identifiers

NCT02151617

B7911001

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 5 patient groups

Cohort 1-PF-06743649 or placebo

Experimental group

Description:

Subjects will be randomized to receive PF-06743649 or placebo as 2 single doses in periods 1 and 2 either in the fed or fasted state followed by once daily dosing for 14 days in period 3

Treatment:

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Drug: PF-06743649

Cohort 2-PF-06743649 or placebo

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Drug: PF-06743649

Cohort 3-PF-06743649 or placebo

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Drug: PF-06743649

Cohort 4-PF-06743649 or placebo

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Drug: PF-06743649

Cohort 5-PF-06743649 or placebo

Experimental group

Treatment:

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Drug: PF-06743649

Drug: PF-06743649

Drug: Placebo

Drug: Placebo

Drug: PF-06743649