A Study To Determine The Effect Of Single-dose PF-04965842 On QTc Interval In Healthy Volunteers Compared With Placebo and Moxifloxacin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-dose, randomized, 3-treatment, 3-period cross-over, sponsor-open,
      placebo-and positive-controlled trial to be conducted in approximately 36 adult healthy
      volunteers. There will be 3 crossover treatments: PF-04965842 600 mg (A), placebo (B) and
      moxifloxacin 400 mg (C). Treatment assignments to PF-04965842 and placebo will be blinded to
      the subjects, investigator and Clinical Research Unit (CRU) staff (except pharmacist) but
      open to the sponsor. Moxifloxacin administration will be unblinded. Dosing in each of the 3
      treatment periods will be separated by a washout period of at least 5 days

      Screening evaluation will occur within the 28 days prior to dosing in the first treatment
      period. During each treatment period, eligible subjects who meet the entry criteria will be
      admitted on Day -1, prior to treatment administration on Day 1, and will reside in the CRU
      until completion of protocol assessments on Day 2. There will be a washout of at least 5 days
      between dose administrations in consecutive crossover treatment periods. After completion of
      the 3 study periods or upon withdrawal from the study, subjects will return for a follow-up
      visit approximately 7-14 days following last dose of investigational product. Further
      follow-up contact will be made at least 28 calendar days and up to 35 calendar days after the
      last administration of the investigational product to capture any potential AEs and
      concomitant treatments, and to confirm appropriate contraception usage, contact with the
      subject may be done via phone. For each subject, the duration of participation from Day 1
      admission to follow-up visit will be approximately 10 weeks. The follow-up call will occur up
      to 4 weeks after the follow-up visit.

      In each treatment period, the subject will be admitted to the CRU the day prior to dosing.
      Genotyping samples for CYP2C19 and CYP2C9 will be collected pre-dose in Period 1 only. The
      subject will receive a single dose of the assigned trial medication in the morning of Day 1.
      Triplicate 12-lead ECG measurements (approximately 2 minutes apart) will be performed on Days
      1 and 2 of each treatment period as follows: -1, -0.5 and 0 hours pre-dose and at 0.25, 0.5,
      1, 2, 3, 6, 12, and 24 hours post-dose. Blood samples will be collected following the 0 hour
      and post-dose ECG measurements at the same time-points to evaluate the PK of PF-04965842 and
      moxifloxacin (if needed). Clinical safety laboratory tests will be performed on Day -1 and at
      24 hours on Day 2, and vital signs (supine pulse rate and BP) will be monitored pre-dose and
      at 2 and 6 hours post-dose on Day 1 and at 24 hours on Day 2. The subject will be discharged
      from the CRU after completing all trial procedures of the particular treatment period in the
      morning of Day 2 (24 hours post-dose).
    


Intervention name(s): PF-04965842; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): one single dose of 600 mg by mouth; one single dose of 400 mg by mouth; one single dose by mouth
Intervention MeSH terms: Moxifloxacin; Abrocitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: healthy volunteers