NCT02807207

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	A: pacritinib	Treatment A
OTHER	B: Placebo	Treatment B
DRUG	C: moxifloxacin	Treatment C

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2016-06-21
• Last updated: 2023-09-15

Locations

1 site across 1 country: United States