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

NCT02807051 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-01-29

No results posted yet for this study

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.

Conditions

  • Drug Interaction Study

Interventions

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

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • CTI BioPharma

    lead INDUSTRY

Principal Investigators

  • Frank Farmer, MD, PhD · 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
2014-09-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807051 on ClinicalTrials.gov