A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

Pfizer16 enrolled

Overview

The purpose of this study is to estimate the effect of itraconazole on the single dose pharmacokinetics of PF-06463922 in healthy volunteers in the fasted state.

This will be a Phase 1, open-label, 2-period, fixed-sequence, crossover study to investigate the effect of the strong CYP3A inhibitor itraconazole on PF-06463922 PK in approximately 16 healthy volunteers. The study will consist of potentially up to 6 treatments: single dose of PF-06463922 50, 75 or 100 mg and PF-06463922 50, 75 or 100 mg in combination with multiple dose itraconazole.

Study Type

INTERVENTIONAL

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

PF-06463922DRUG

Single oral dose of PF-06463922 50 mg on Day 1 of Period 1 and Day 5 of Period 2

PF-06463922DRUG

Single oral dose of PF-06463922 75 mg on Day 1 of Period 1 and Day 5 of Period 2

PF-06463922DRUG

Single oral dose of PF-06463922 100 mg on Day 1 of Period 1 and Day 5 of Period 2

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy female subjects of non childbearing potential and/or male subjects, who at the time of screening, are between the ages of 18 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). 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 the time of dosing). * Any condition possibly affecting drug absorption. * A positive urine drug test. * History of HIV, Hep B or Hep C. * History of regular alcohol consumption. * Screening supine 12 lead ECG demonstrating PR interval \>180 msec, QTc \>450 msec or a QRS interval \>120 msec. * Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary: Use this criterion to describe any laboratory parameters that are not acceptable for the study. Examples included below: * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \>1.0 × upper limit of normal (ULN); * Total bilirubin level \>1.0 × ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is \<= ULN.

Locations (1)

Pfizer Clinical Research Unit

Brussels, Belgium