A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial \[P3CT\] Formulation \[Reference\] and Final Market Image \[FMI\] Formulation \[Test\]) Following Oral Administration in Healthy Subjects
This study will be a Phase 1, open-label, single-dose, randomized, 2-period, 2-treatment sequence crossover study to determine the bioequivalence of pacritinib following administration of 400-mg doses of P3CT (Reference) and FMI (Test) formulations and to characterize the PK of pacritinib. Each subject will receive 2 treatments (a 400-mg oral dose of four 100-mg pacritinib P3CT \[reference\] formulation capsules and a 400-mg oral dose of four 100-mg pacritinib FMI \[test\] formulation capsules) in a 2-period crossover design. Each treatment will be administered as monotherapy during 1 of 2 treatment periods. A 9-day washout will separate the 2 administrations of study medication. Subjects will remain confined to the Clinical Research Unit (CRU) throughout the study for safety observation and PK blood sample collection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
400-mg oral dose of pacritinib P3CT (reference) formulation capsules
400-mg oral dose of pacritinib FMI (test) formulation capsules
Covance Clinical Research Unit Inc.
Evansville, Indiana, United States
The apparent total body clearance (CL/F)
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The maximum plasma concentration (Cmax).
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The area under the plasma concentration-time curve from time zero to time of the last measured concentration above the limit of quantification (AUC0-t).
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The area under the plasma concentration-time curve from zero to infinity (AUC0-∞).
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The time to reach maximum plasma concentration (tmax).
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
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Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
The apparent volume of distribution (Vd)
The following pharmacokinetic parameters of pacritinib were assessed following 400 mg single-dose administration of Clinical trial material or final market image formulations of pacritinib capsule in healthy subjects
Time frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability of pacritinib 400 mg
Time frame: Day 1 to Day 17