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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-16

Study Completion Date

2017-05-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1

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.

Group Type EXPERIMENTAL

PF-06463922

Intervention Type DRUG

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

Itraconazole

Intervention Type DRUG

200 mg oral dose of itraconazole on Days 1 to 11 during Period 2

Cohort 2

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.

Group Type EXPERIMENTAL

PF-06463922

Intervention Type DRUG

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

Itraconazole

Intervention Type DRUG

200 mg oral dose of itraconazole on Days 1 to 11 during Period 2

Cohort 3

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.

Group Type EXPERIMENTAL

PF-06463922

Intervention Type DRUG

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

Itraconazole

Intervention Type DRUG

200 mg oral dose of itraconazole on Days 1 to 11 during Period 2

Cohort 4

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.

Group Type EXPERIMENTAL

PF-06463922

Intervention Type DRUG

Highest safe single oral dose (mg) of PF-06463922 identified in the previous cohorts will be administered on Day 1 of Period 1 and Day 5 of Period 2

Itraconazole

Intervention Type DRUG

200 mg oral dose of itraconazole on Days 1 to 11 during Period 2

Interventions

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PF-06463922

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

Intervention Type DRUG

PF-06463922

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

Intervention Type DRUG

PF-06463922

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

Intervention Type DRUG

PF-06463922

Highest safe single oral dose (mg) of PF-06463922 identified in the previous cohorts will be administered on Day 1 of Period 1 and Day 5 of Period 2

Intervention Type DRUG

Itraconazole

200 mg oral dose of itraconazole on Days 1 to 11 during Period 2

Intervention Type DRUG

Other Intervention Names

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Lorlatinib Lorlatinib Lorlatinib Lorlatinib Sporanox

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes