To Evaluate the Cardiac Safety and PK Following a Single Oral Dose Administration of Pacritinib in Healthy Subjects

Healthy Subjects Clinical Trial

Official title: A Phase 1, Single-Center, Pacritinib- Versus Placebo-Blinded, Active- and Placebo-Controlled, Randomized, 3-Way Crossover Study to Evaluate the Cardiac Safety and Pharmacokinetics Following a Single Oral Dose Administration of Pacritinib in Healthy Subjects

Status Completed

Clinical Trial Summary

The primary objective is to evaluate the cardiac safety of a single oral dose (400 mg) of pacritinib compared to placebo on the QT calculated using the Fridericia correction (QTcF) interval in healthy subjects.

Clinical Trial Description

This is a randomized, pacritinib- versus placebo-blind, placebo- and active-controlled, single-dose, single-center, 3-period crossover study to evaluate the cardiac safety of a single 400-mg dose of pacritinib compared to placebo, and to characterize the PK of pacritinib and major human metabolites of pacritinib. The study is blinded for pacritinib and placebo, and open-label for moxifloxacin.

Subjects were to receive 3 treatments (400 mg pacritinib, placebo, and 400 mg moxifloxacin) in a crossover fashion. Each treatment is administered as monotherapy during 1 of 3 treatment periods with a 7-day washout period between administration of each study medication. Screening occurred up to 28 days before Check-in (Day -1) of Period 1. On Day -1 of Period 1, subjects checked into the Clinical Research Unit (CRU) for baseline assessments and were confined to the CRU for the remainder of the study until Study Completion (Day 22)/Early Termination. Continuous 12-lead cardiodynamic ECG monitoring and recording was performed from predose (at least

1 hour before administration of study medication) through 24 hours after the administration of study medication, then for 15 minutes every 12 hours (on Days 2 to 7 of each period). Blood samples for PK analysis were also collected predose (Hour 0) and at each cardiodynamic ECG timepoint postdose. Safety endpoints (eg, adverse events [AEs], clinical laboratory evaluations, vital signs) were monitored throughout each period. Subjects were discharged at Study Completion (Day 22). Subjects were scheduled to return for a Follow-up Visit 14 days (±3 days) later on Day 36. ;

Related Conditions & MeSH terms

• Healthy Subjects

• NCT number: NCT02807207
• Study type: Interventional
• Source: CTI BioPharma
• Status: Completed
• Phase: Phase 1
• Start date: October 2014
• Completion date: December 2014