NCT02823171

To Assess the Bioequivalence of Two Pacritinib Drug Product Formulations and FMI Formulation Following Oral Administration in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Treatment A: 400 mg Pacritinib P3CT	400-mg oral dose of pacritinib P3CT (reference) formulation capsules
DRUG	Treatment B: 400 mg of pacritinib FMI	400-mg oral dose of pacritinib FMI (test) formulation capsules

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2016-07-06
• Last updated: 2023-09-15

Locations

1 site across 1 country: United States