Dermatitis, Atopic Clinical Trial
Official title:
A PHASE 1, OPEN-LABEL, RANDOMIZED, FIXED-SEQUENCE, PARALLEL-COHORT STUDY TO ESTIMATE THE EFFECT OF FLUVOXAMINE OR FLUCONAZOLE, ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF A SINGLE DOSE OF PF-04965842 IN HEALTHY SUBJECTS
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.
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