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

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
CTI BioPharma
Study ID
NCT02807116
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 31, 2015
Status verified
Jun 2016
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Pacritinib and Rifampin
    On Day 1, subjects received a single oral 400-mg dose of pacritinib. On Days 8 through 17, following a 7-day washout period, 600-mg oral doses of rifampin were administered QD. 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.

Primary Outcome Measure

Estimate ratios of geometric mean values and the corresponding 90% confidence intervals (CIs) for pacritinib treatments with and without rifampin [ Time Frame: Approx. one month ]

Locations (1)

FacilityCityStateZIPSite coordinators
Covance Clinical Research UnitDaytona BeachFlorida32117-

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By research site
Covance Clinical Research Unit· Daytona Beach, FL

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