A Study to Assess Pharmacokinetics of PF-04965842 and Its Metabolites and Effect of Probenecid in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    


Intervention name(s): PF-04965842; Probenecid
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be administered a single oral 200 mg dose of PF-04965842 in the morning on Period 1 Day 1 and Period 3 Day 2 under fasted conditions. 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; 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.
Intervention MeSH terms: Probenecid; Abrocitinib
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: healthy volunteers