Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 In Healthy Adult Subjects

Pfizer8 enrolled

Overview

The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.

Study Type

INTERVENTIONAL

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-06291874DRUG

PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 75 mg to 500 mg.

placeboOTHER

Correspondingly, placebo doses will be administered as suspension.

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and/or female subjects of non childbearing potential. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Time frame: 0-72/dose

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)]

Time frame: 0-72/dose

Maximum Observed Plasma Concentration (Cmax)

Time frame: 0-72/dose

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: 0-72/dose

Plasma Decay Half-Life (t1/2)

Time frame: 0-72/dose

Apparent Oral Clearance (CL/F)

Time frame: 0-72/dose

Apparent Volume of Distribution (Vz/F)

Time frame: 0-72/dose

Data from ClinicalTrials.gov

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