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 |
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.
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.
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
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