A Phase 1, Double Blind (Sponsor Open), Placebo-controlled, Multiple-dose Study To Evaluate The Tolerability, Safety And Pharmacokinetics Of A Modified Release Formulation Of Pf-06650833 Under Fed Condition In Healthy Adult Japanese Subjects

Pfizer1 site in 1 country10 target enrollmentAugust 2016

ConditionsHealthy

Interventionsplacebo PF-06650833

DrugsPF-06650833 placebo

Overview

Phase: Phase 1
Intervention: placebo
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 10
Locations: 1
Primary Endpoint: Number of participants experiencing an AE/SAE
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the tolerability, safety and pharmacokinetics of PF-06650833 orally administered as modified release tablets in healthy Japanese subjects.

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

October 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy female subjects of non childbearing potential and/or male Japanese subjects between the ages of 20 and 55 years, inclusive.
•Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
•Subject must have four Japanese grandparents who were born in Japan.
•Evidence of a personally signed and dated informed consent document.
•Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
•Any condition possibly affecting drug absorption (eg, gastrectomy).
•A positive urine drug screen.
•Smoking cigarettes with exceeding provided criteria.
•History of regular alcohol consumption exceeding provided limitations.
•Treatment with an investigational drug within a provided criteria.
•Abnormal supine blood pressure.
•Abnormal pulse rate.
•Abnormal 12 lead ECG.
•History of tuberculosis.

Arms & Interventions

placebo

Intervention: placebo

300 mg

Intervention: PF-06650833

Outcomes

Primary Outcomes

Number of participants experiencing an AE/SAE

Time Frame: Day 18

Secondary Outcomes

Clearance(Day 10)
Mean residence time(Day 10)
Volume of distribution(Day 10)
Time to peak concentration(Day 1 and Day 10)
Minimum plasma concentration (Cmin)(Days 2, 4, 7 and 10)
Fluctuation ratio (Cmax:Cmin)(Day 10)
Maximum plasma concentration (Cmax)(Day 1 and Day 10)
Area under the plasma concentration time curve for dosing interval (AUCtau)(Day 1 and Day 10)
Observed exposure accumulation ratio for AUCtau(Day 10)
Observed exposure accumulation ratio for Cmax(Day 10)
change from baseline in vital signs(Day 18)
Incidence of treatment emergent clinical laboratory abnormalities(Day 18)
change form baseline in electrocardiogram (ECG) parameters(Day 18)