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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:1/27/2019
Start Date:July 2016
End Date:October 2016

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A Phase One, Open Label, Two-period, Two-treatment, Fixed Sequence, Cross-over Study To Estimate The Effect Of Multiple Dose Rifampin On The Single Dose Pharmacokinetics Of Pf-06463922 In Healthy Volunteers.

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

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.

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
We found this trial at
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New Haven, Connecticut 06511
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New Haven, CT
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