NCT02807116

Drug-Interaction Study to Evaluate the Effect of Rifampin, a Potent CYP3A4 Inducer, on the Systemic Exposure of Pacritinib in Healthy Subjects

A Phase 1, Open-Label, Drug-Interaction Study to Evaluate the Effect of Rifampin, a Potent CYP3A4 Inducer, on the Systemic Exposure of Pacritinib in Healthy Subjects

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

Summary

The primary objective is to evaluate the effect of rifampin, a potent cytochrome P450 3A4 inducer, at steady-state on the systemic exposure of a single dose of pacritinib in healthy subjects.

Detailed description

This was a single-center, open-label, one-way crossover, drug-interaction study. On Day 1, subjects received a single oral 400-mg dose of pacritinib. Following a 7-day washout period, 600-mg oral doses of rifampin were administered once daily (QD) on Days 8 through 17. It was anticipated that steady-state concentrations of rifampin would be achieved by Day 17. On Day 17, a single oral 400-mg dose of pacritinib was co-administered with the final 600-mg dose of rifampin.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Pacritinib	Subjects received a single oral 400-mg dose of pacritinib
DRUG	Rifampin	Subjects received 600-mg oral doses of rifampin; administered QD following a 7-day washout period
DRUG	Pacritinib and Rifampin	On Day 17, a single oral 400-mg dose of pacritinib was co-administered with the final 600-mg dose of rifampin.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2016-06-21
• Last updated: 2023-09-15

Locations

1 site across 1 country: United States