This open label study will evaluate the pharmacokinetics (PK) following single oral doses of different formulations of PF-06882961, including controlled release (CR) tablets at 2 release rates (long and short duration), an immediate release (IR) oral solution, and IR tablets, in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Immediate Release Tablet
Controlled Release tablet (long)
Controlled Release tablet (short)
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States
Maximum Observed Plasma Concentration (Cmax) for PF-06882961
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Time to Maximum Observed Plasma Concentration (Tmax) for PF-06882961
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Area under the curve from time zero to last quantifiable concentration for PF-06882961 (AUClast)
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Area under the curve from time zero to extrapolated infinite time for PF-06882961 (AUCinf), as data permit
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Observed Plasma Concentration for PF-06882961 at 24 hours post-dose (C24)
Time frame: 24 hours post dose in each period
Plasma Decay Half-Life (t1/2) for PF-06882961, as data permit
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Apparent clearance (CL/F) for PF-06882961, as data permit
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Calculated as Dose/AUCinf
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
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PF-06882961 Immediate Release solution
Peak-to-trough (PTR) ratio for PF-06882961
Calculated as ratio of Cmax to C24
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period
Number of subjects with treatment-emergent adverse events (AEs)
Assessment by adverse event monitoring, 12 lead ECGs, vital signs and clinical safety laboratory measurements.
Time frame: Baseline to at least 28 days after last dose
AUClast for PF-06882961 for CR tablet (long) and IR tablet in fed state
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
AUCinf for PF-06882961 for CR tablet (long) and IR tablet in fed state, as data permit
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
Cmax for PF-06882961 for CR tablet (long) and IR tablet in fed state
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
AUClast for PF-06882961 for CR tablet (long) in fed and fasted states
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
AUCinf for PF-06882961 for CR tablet (long) in fed and fasted states, as data permit
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose
Cmax for PF-06882961 for CR tablet (long) in fed and fasted states
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose