NCT02803762

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

A Phase 1, Open-Label Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of [14C] Pacritinib Following a Single Oral Dose in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The present study is designed to investigate the absorption, metabolism, excretion as well as safety/tolerability of pacritinib following the administration of a single oral dose to healthy male volunteers. The pacritinib dose is administered with a \[14C\]-labeled form to enable detection and quantitation of dose-related material independent of possible biotransformation. The study design allows detection of potential human specific metabolites that have not been detected in the animal species. Subjects are confined at the clinical site from the time of Check-in until Day 14 post-dose, but may be discharged from the clinical site between Day 10 and 13 post-dose if study discharge criteria are met (i.e. completion of sufficient radioactivity excretion). All remaining subjects will be discharged from the clinical site on Day 14 post-dose irrespective of the study discharge criteria. The data obtained in this study will be used for the further clinical development of the compound.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pacritinib	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

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2016-06-17
• Last updated: 2016-06-17

Locations

1 site across 1 country: Netherlands