To Evaluate the Cardiac Safety and PK Following a Single Oral Dose Administration of Pacritinib in Healthy Subjects

Part of paid clinical trials in Evansville, Indiana.

Sponsor
CTI BioPharma
Study ID
NCT02807207
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • A: pacritinib — DRUG
    Treatment A
  • B: Placebo — OTHER
    Treatment B
  • C: moxifloxacin — DRUG
    Treatment C

Study Details

The primary objective is to evaluate the cardiac safety of a single oral dose (400 mg) of pacritinib compared to placebo on the QT calculated using the Fridericia correction (QTcF) interval in healthy subjects.

Key Dates

Start date
Oct 31, 2014
Status verified
Jun 2016
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

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

Arms

  • Experimental: Sequence I
    treatment sequence: A/B/C
  • Experimental: Sequence II
    treatment sequence: A/C/B
  • Experimental: Sequence III
    treatment sequence: B/A/C
  • Experimental: Sequence IV
    treatment sequence: B/C/A
  • Experimental: Sequence V
    treatment sequence: C/A/B
  • Experimental: Sequence VI
    treatment sequence: C/B/A

Primary Outcome Measure

QT calculated using Fridericia correction (QTcF) interval [ Time Frame: ECG: 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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