A Phase 1, Open Label, Parallel-Cohort, Randomized, Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between PF-04965842 and Fkuvoxamine (cohort 1) or Fluconazole (Cohort 2) in healthy subjects.
A phase 1 study to evaluate the effect of fluvoxamine (a strong CYP2C19 and moderate CYP3A inhibitor) or fluconazole (a strong CYP2C19, moderate CYP2C9 and CYP3A inhibitor) on the pharmacokinetics, safety and tolerability of PF-04965842 in healthy subjects. This study will be a Phase 1, open label, randomized, fixed-sequence, parallel-cohort study drug-drug interaction study. The study includes 2 periods: In Period 1: all subjects will receive one single oral dose of 100 mg PF 04965842 tablet. (Treatment A). PK will be evaluated in the first 72 hours post adminstration of PF 04965842. In Period 2: * Cohort 1: subjects will receive fluvoxamine (immediate release tablet 50 mg) once daily for 9 consecutive days; on Day 8, subjects will receive a single oral dose of 100 mg PF 04965842 approximately 3 hours after fluvoxamine administration. (Treatment B). PK will be evaluated in the first 72 hours post administration of PF 04965842. * Cohort 2: subjects will receive fluconazole capsule(s) once daily for 7 consecutive days (400 mg on Day 1 and 200 mg on Day 2-7 in Period 2); on Day 5, subjects will receive a single oral dose of 100 mg PF 04965842 approximately 1 hour after fluconazole administration. (Treatment C). PK will be evaluated in the first 72 hours post administration of PF 04965842.
Study Type
INTERVENTIONAL
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Period 1: Single administration of 100 mg PF 04965842.
Cohort 1: Period 2: Administration of fluvoxamine from Day 1 to Day 9 and PF-04965842 on Day 8.
Cohort 2: Period 2: Administration of fluconazole from Day 1 to Day 7 and PF-04965842 on Day 5.
Pfizer Clinical Research Unit
Brussels, Belgium
Plasma Cmax for PF 04965842
Maximum Observed Plasma Concentration (Cmax) for PF 04965842
Time frame: First 72 hours post PF-04965842 administration in Period 1 and Period 2
AUCinf for PF-04965842
Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF 04965842 (AUCinf)
Time frame: First 72 hours post PF-04965842 administration in Period 1 and Period 2
Number of subjects with Adverse events (AEs)
Number of subjects with Adverse events (AEs)
Time frame: Screening up to 28 Days after the Last Dose of PF 04965842
Number of subjects with laboratory tests findings of potential clinical importance
Number of subjects with laboratory tests findings of potential clinical importance
Time frame: Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2
Number of Subjects with clinically significant abnormal Vital Signs
Number of Subjects with clinically significant abnormal Vital Signs
Time frame: Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2
Number of Subjects with Electrocardiograms (ECGs) findings of potential clinical importance
Number of Subjects with Electrocardiograms (ECGs) findings of potential clinical importance
Time frame: Screening up to 7-14 Days after the Last Dose of PF 04965842 in Period 2
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