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

Part of paid clinical trials in Evansville, Indiana.

Sponsor
CTI BioPharma
Study ID
NCT02823171
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Aug 31, 2015
Status verified
Jun 2016
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Sequence I
    Sequence I: treatment A/B
  • Experimental: Sequence II
    Sequence II: treatment B/A

Primary Outcome Measure

The apparent total body clearance (CL/F) [ Time Frame: Plasma: 0, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, and 168 hrs post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Covance Clinical Research Unit Inc.EvansvilleIndiana47710-

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Covance Clinical Research Unit Inc.· Evansville, IN

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