Healthy Clinical Trial
Official title:
A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO ASSESS SINGLE DOSE AND MULTIPLE DOSE PHARMACOKINETICS OF PF-04965842 AND ITS METABOLITES, AND THE EFFECT OF REPEAT-DOSE PROBENECID ON THE SINGLE DOSE PHARMACOKINETICS OF PF-04965842 AND ITS METABOLITES IN HEALTHY PARTICIPANTS
A total of approximately 12 healthy male or female participants will be enrolled in the study
so that at least 10 participants will complete the study.
Participants will be screened within 28 days of the first dose of study medication. The
single fixed-sequence will consist of 3 periods. Participants will report to the clinical
research unit (CRU) at least 12 hours prior to Day 1 dosing in Period 1 and will be required
to stay in the CRU for 12 days and 11 nights. Genotyping samples for cytochrome P450 (CYP)
2C19 and CYP2C9 will be collected pre dose in Period 1 only.
In Period 1, participants will be administered a single oral 200 mg dose of PF-04965842 in
the morning on Day 1 under fasted conditions (overnight fasting for at least 10 hours). No
food will be allowed for at least 4 hours postdose and undergo serial blood sample collection
for 48 hours postdose.
In Period 2, participants will receive oral 200 mg dose of PF-04965842 once daily (QD) in the
morning of Day 1 to Day 4 under fasted conditions (overnight fasting for at least 10 hours).
No food will be allowed for at least 4 hours postdose and undergo serial blood sample
collection for 48 hours postdose on Day 4.
In Period 3, participants will receive probenecid 1000 mg twice daily (BID) in the mornings
and evenings of Day 1 to Day 3. On the morning of Period 3 Day 2, after an overnight fast of
approximately 8 hours, participants will be administered probenecid 1000 mg. A single 200 mg
oral dose of PF 04965842 will be administered approximately 2 hours after the probenecid
dose. Participants will remain in a fasted state for 4 hours after dosing with PF 04965842
and undergo serial blood sample collection for 48 hours post PF 04965842 dosing. Participants
will be discharged from the CRU on Day 4 after all study procedures are completed. The
participant will be required to have a Follow-up phone contact 28-35 days after the last dose
of investigational product.
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