NCT02808455

Study to Assess the Relative Bioavailability of Pacritinib Following Oral Administration as Capsule and Solution Formulations in Healthy Subjects

A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period, 2-Treatment-Sequence Crossover Study to Assess the Relative Bioavailability of Pacritinib Following Oral Administration as Capsule and Solution Formulations in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This was a randomized, 2-period, 2-treatment-sequence crossover study to determine the relative bioavailability of pacritinib following administration as a 400 mg oral dose of four 100 mg pacritinib capsules and an 80 mg dose of an oral solution and to characterize the PK and major human metabolites of pacritinib.

Detailed description

Twelve healthy subjects will be enrolled in the study (6 subjects per sequence) at a single clinical site with the intent that 12 subjects complete Periods 1 and 2 in the study. Subjects will be randomly assigned to 2 possible sequences (6 subjects per sequence) on Day 1 of Period 1. Subjects will be randomly assigned to 2 possible sequences. Each subject received 2 treatments (a 400 mg oral dose of four 100 mg pacritinib capsules and an 80 mg oral solution dose of pacritinib) in a 2-period crossover design. Each treatment will be administered as monotherapy during 1 of 2 treatment periods with a 7-day washout period between administrations of each study medication.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	(Treatment A)	Four 100-mg capsules of pacritinib administered as a single oral dose
DRUG	(Treatment B)	A single 80-mg oral solution dose of pacritinib

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2016-06-21
• Last updated: 2023-09-15

Locations

1 site across 1 country: United States