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To Assess the Bioequivalence of Two Pacritinib Drug Product Formulations and FMI Formulation Following Oral Administration in Healthy Subjects

NCT02823171 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-09-15

No results posted yet for this study

Summary

A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial \[P3CT\] Formulation \[Reference\] and Final Market Image \[FMI\] Formulation \[Test\]) Following Oral Administration in Healthy Subjects

Conditions

  • Healthy

Interventions

DRUG

Treatment A: 400 mg Pacritinib P3CT

400-mg oral dose of pacritinib P3CT (reference) formulation capsules

DRUG

Treatment B: 400 mg of pacritinib FMI

400-mg oral dose of pacritinib FMI (test) formulation capsules

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • CTI BioPharma

    lead INDUSTRY

Principal Investigators

  • Kelly Whitehurst, MD · Covance Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-09-30
Completion
2015-09-30

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 NCT02823171 on ClinicalTrials.gov