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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-06463922; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02838264

B7461012

ITRACONAZOLE DDI STUDY (Other Identifier)

2016-002386-57 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

16 participants in 4 patient groups

Cohort 1

Experimental group

Description:

All subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive PF-06463922 Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2.

Treatment:

Drug: PF-06463922

Drug: PF-06463922

Drug: Itraconazole

Drug: PF-06463922

Drug: PF-06463922

Cohort 2

Experimental group

Description:

All subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive PF-06463922 Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2.

Treatment:

Drug: PF-06463922

Drug: PF-06463922

Drug: Itraconazole

Drug: PF-06463922

Drug: PF-06463922

Cohort 3

Experimental group

Description:

All subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive PF-06463922 Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2.

Treatment:

Drug: PF-06463922

Drug: PF-06463922

Drug: Itraconazole

Drug: PF-06463922

Drug: PF-06463922

Cohort 4

Experimental group

Description:

All subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive the highest safe dose (mg) of PF-06463922 as a single-dose Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2.

Treatment:

Drug: PF-06463922

Drug: PF-06463922

Drug: Itraconazole

Drug: PF-06463922

Drug: PF-06463922