The purpose of the study is to evaluate the effect of formulation on relative bioavailability of PF-06882961.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
31
PF-06882961 100 mg will be provided in 5 different oral formulations A, B, C, D, and E. Cohort 1 is a randomized, open-label, single dose, 4-period, 4-sequence, crossover design where the first 2 periods are cross-over (Formulations A and B) and the second 2 periods are crossover (Formulations C and D). Cohort 2 is a randomized, open-label, single dose, 2-period, 2 sequence, crossover design (Formulations A and E)
Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région de, Belgium
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations A and B cohort 1
Time frame: Day 1 hour (hr) 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 and end of study (Day 28)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations A and B cohort 1
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Maximum Observed Plasma Concentration (Cmax) for Formulations A and B cohort 1
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations A and E cohort 2
Time frame: Day 1 hour (hr) 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 and end of study (Day 28)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations A and E cohort 2
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Maximum Observed Plasma Concentration (Cmax) for Formulations A and E cohort 2
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Number of Subjects Reporting Treatment-emergent adverse events (AEs)
Time frame: Baseline through End of Study(Day 28)
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Baseline, Day 1 and Day 3
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Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline, Day 1 and Day 3
Number of Participants With Abnormal Electrocardiogram (ECG)
Time frame: Baseline, Day 1 and Day 3
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations C and D
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations C and D
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48
Maximum Observed Plasma Concentration (Cmax) for Formulations C and D
Time frame: Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48