NCT02807051

To Evaluate the Effect of Clarithromycin on the Systemic Exposure of Pacritinib in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This will be an open-label, single-center, crossover, one-way, drug-interaction study to evaluate the effect of 500 mg clarithromycin BID (dosed to steady state) on the PK of a single 400-mg dose of pacritinib in healthy male and female 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. On Day 8 through the morning of Day 12, following a 7-day washout period, 500-mg oral doses of clarithromycin were administered twice daily (BID), 8 to 12 hours apart. It was anticipated that steady-state concentrations of clarithromycin would be achieved by Day 12. On Day 12, a single oral 400-mg dose of pacritinib was co-administered with the final 500-mg dose of clarithromycin.

Conditions

• Drug Interaction Study

Interventions

Type	Name	Description
DRUG	Pacritinib	Single 400-mg dose (four 100-mg capsules) administered in the morning on Days 1 and 12
DRUG	Clarithromycin	Twice-daily, 500-mg dose (one 500-mg tablet) administered every 8 to 12 hours on Day 8 through the morning of Day 12
DRUG	Pacritinib and Clarithromycin	On Day 12, a single oral 400-mg dose of pacritinib was co-administered with the final 500-mg dose of clarithromycin

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2016-06-21
• Last updated: 2020-01-29

Locations

1 site across 1 country: United States