Bioavailability Study of PF-06651600 Formulations in Healthy Participants

Pfizer12 enrolled

Overview

The study will be conducted as a Phase 1, open-label, single dose, randomized, 4-period, cross over design in a single cohort of approximately 12 healthy male or female participants at a single center. Participants will be randomized into 1 of 4 sequences of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

PF-06651600DRUG

PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

INCLUSION CRITERIA: * Participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and 12 lead ECG. * Participants with body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). EXCLUSION CRITERIA * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). * Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency. * Infection with hepatitis B or hepatitis C viruses

Locations (1)

Brussels Clinical Research Unit

Brussels, Be-bru, Belgium

Outcomes

Primary Outcomes

Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600