This will be an investigator- and subject-blinded (sponsor open), randomized, placebo controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional sixth and seventh cohorts). A total of approximately 50 (if 5 cohorts), 60 (if 6 cohorts), and up to 70 (if 7 cohorts) subjects will be randomized in this study. Subjects in each cohort will be randomized to receive PF-06865571 or matching placebo with approximately 10 subjects dosed in each cohort. For a given subject in any cohort, the total study duration from screening to follow-up phone call will be between approximately 7 to 11 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
60
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Matching Placebo for PF-06865571 for each cohort.
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States
Pfizer Clinical Research Unit
Brussels, Belgium
Number of subjects with adverse events (AEs)
Number of participants with reported adverse events
Time frame: Baseline up to 35 days after last dose of study medication
Number of subjects with laboratory tests findings of potential clinical importance
Number of participants with potentially clinically important laboratory test findings
Time frame: Baseline (Day 0) up to 24 days after last dose of study medication
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Number of participants with potentially clinically important ECG findings
Time frame: Baseline (Day 0) up to 24 days after last dose of study medication
Number of subjects with vital signs findings of potential clinical importance
Number of participants with potentially clinically important vital sign measurements
Time frame: Baseline (Day 0) up to 24 days after last dose of study medication
Maximum Observed Plasma Concentration (Cmax) for PF-06865571
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
AUCtau for PF-06865571
Area under the concentration-time curve calculated by linear trapezoidal rule from time zero to the end of the dosing interval (i.e., 24 h) at steady state.
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Time to Reach Maximum Observed Concentration for PF-06865571
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Dose normalized Cmax for PF-06865571
Following log-transformation, dose normalized Cmax will be analysed using a mixed model appropriate to the study design.
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Amount of unchanged drug recovered in urine during the dosing interval (Aetau) for PF-06865571
Sum of \[urine concentration \* sample volume\] for each collection over the dosing interval
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
Percent of dose recovered in urine as unchanged drug (Aetau %) for PF-06865571
100\* Aetau/Dose
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
Renal clearance (CLr) for PF-06865571
Aetau/AUCtau
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
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