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

Conditions

• Drug Interaction Study

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Sep 30, 2014

Status verified

Jan 2020

Primary completion

Oct 31, 2014

Completion

Oct 31, 2014

Study Design

Enrollment

20 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: Pacritinib and Clarithromycin
  Single 400-mg (four 100-mg capsules; lot number 21341) oral doses of pacritinib were administered in the fasted state on Days 1 and 12. Twice daily, 500-mg (1 tablet) oral doses of clarithromycin were administered with or without food on Days 8 through 11 and in the fasted state on the morning of Day 12

Primary Outcome Measure

Estimate ratios of geometric mean values and the corresponding 90% confidence intervals (CIs) for pacritinib treatments with and without clarithromycin [ Time Frame: Fifteen days approximately ]

Locations (1)

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