Investigate Absorption, Metabolism, Excretion, and Mass Balance of Pacritinib

Sponsor
CTI BioPharma
Study ID
NCT02803762
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Pacritinib — DRUG
    400 mg \[14C\]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose following at least a 10-hour fast (not including water) on Day 1

Study Details

This study is an open-label, absorption, metabolism, excretion, and mass balance study of 400 mg \[14C\]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose to 6 healthy male subjects following at least a 10-hour fast (not including water) on Day 1.

Key Dates

Start date
Jul 31, 2014
Status verified
May 2016
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP

Arms

  • Experimental: Investigational: [14C] Pacritinib
    All enrolled subjects are checked in the day before drug administration. Following at least a 10-hour fast (not including water), each subject will receive an oral dose of 400 mg \[14C\]pacritinib (containing 100 μCi radioactivity).

Primary Outcome Measure

The maximum plasma concentration (Cmax) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14 ]

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