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

NCT02807116 Phase 1 COMPLETED

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.

Details

Lead sponsor	CTI BioPharma
Phase	Phase 1
Status	COMPLETED
Enrolment	18
Start date	2015-01
Completion	2015-02

Conditions

• Healthy Subjects

Interventions

• Pacritinib
• Rifampin
• Pacritinib and Rifampin

Primary outcomes

• Estimate ratios of geometric mean values and the corresponding 90% confidence intervals (CIs) for pacritinib treatments with and without rifampin — Approx. one month
  Estimate ratios of geometric mean values and the corresponding 90% confidence intervals (CIs) for pacritinib treatments with and without rifampin to assess the potential for clinical interaction with CYP3A4 inducers.

Countries

United States