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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-10-31

Brief Summary

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The purpose of this study is to estimate the effect of rifampin on the single dose PK of PF-06463922.

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Detailed Description

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This will be a Phase 1, open-label, 2-period, 2-treatment, fixed-sequence, cross-over study in approximately 12 healthy subjects employing administration of a single oral dose of PF-06463922 in the fasted state alone, and with multiple dosing of rifampin 600 mg once a day to estimate the effect of multiple dose rifampin on the single dose PK of PF-06463922.

Conditions

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Healthy

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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all subjects

subjects will receive a 100 mg single oral dose of PF-06463922 followed by a 100 mg single dose of PF-06463922 combined with 600 mg QD dose of rifampin with at least 10 days of washout period between two PF-06463922 doses.

Group Type EXPERIMENTAL

PF-06463922

Intervention Type DRUG

100 mg oral dose on day 1 in period 1 and on day 8 in period 2

rifampin

Intervention Type DRUG

600 mg QD from day 1 to day 12 in period 2.

Interventions

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PF-06463922

100 mg oral dose on day 1 in period 1 and on day 8 in period 2

Intervention Type DRUG

rifampin

600 mg QD from day 1 to day 12 in period 2.

Intervention Type DRUG

Other Intervention Names

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lorlatinib rifampicin

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
* Any condition possibly affecting drug absorption
* Positive urine drug screen
* History of HIV, Hep B or Hep C
* History of regular alcohol consumption
* History of cardiac arrhythmia, history of AV block, history of symptomatic bradycardia, history of QTc prolongation
* History of pancreatitis or hyperlipidemia, elevated lipase

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes