Bioavailability Study Of PF-06651600 In Healthy Subjects

Pfizer14 enrolled

Overview

PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed under fasting and fed conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

PF-06651600DRUG

PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential. * BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * Prior history of chicken pox. * Evidence of personally signed and dated informed consent document. * Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures. Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males. * Screening blood pressure \>140/90 mm Hg. * Screening laboratory abnormalities as defined by the protocol. * Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.

Locations (1)

Pfizer Clinical Research Unit

Brussels, Belgium