Drug-Interaction Study to Evaluate the Effect of Rifampin, a Potent CYP3A4 Inducer, on the Systemic Exposure of Pacritinib in Healthy Subjects
NCT02807116 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2023-09-15
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.
Conditions
- Healthy Subjects
Interventions
- DRUG
-
Pacritinib
Subjects received a single oral 400-mg dose of pacritinib
- DRUG
-
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.
Sponsors & Collaborators
-
Covance
collaborator INDUSTRY -
CTI BioPharma
lead INDUSTRY
Principal Investigators
-
Hugh A Coleman, DO · Covance
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2015-02-28
- Completion
- 2015-02-28
Countries
- United States
Study Locations
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