NCT02030639

Metabolism and Excretion of [14C]-Rigosertib After Infusion to Volunteers

Phase I Study of the Metabolism and Excretion of [14C]-Rigosertib After Single-dose Administration as 24-hour Continuous Intravenous Infusion to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Traws Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to gain an understanding of how the experimental anti-cancer drug, rigosertib, is metabolized in the body and excreted in the urine and feces after it is given as an intravenous infusion. In addition, the study will be carefully monitored to see if any side effects occur. A radioactive drug is used in this study because it is easier and more accurate to measure radioactivity than to use more complicated and less sensitive chemical tests for the drug.

Detailed description

This study will be an open-label, non-randomized, metabolism and excretion study of \[14C\]-rigosertib administered as a single dose of approximately 450 mg containing 250 μCi \[14C\]-labeled rigosertib as a 24-hour continuous intravenous (CIV) infusion in healthy volunteers. Up to 8 subjects will be enrolled to ensure at least 6 subjects have evaluable data. Eligible subjects will be confined at the clinical site from the time of Check-in (approximately 24 hours prior to dosing) until Discharge (between Days 6 and 10). One single dose of \[14C\]-rigosertib will be administered as a 24-hour continuous intravenous infusion on Day 1. Subjects will be discharged as early as 120 hours after the start of the infusion, after ≥ 90% of the administered radioactive dose has been recovered in urine and feces or when the combined total radioactivity recovered in urine and feces is ≤ 1% of the administered radioactive dose for 2 consecutive 24-hr samples. The maximum stay will be until Day 10 (216 hours after the start of the infusion).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	rigosertib	A single dose of 450 mg of rigosertib containing 250 microcuries of carbon 14-labeled rigosertib (\[14C\]-rigosertib) administered as a continuous intravenous (CIV) infusion over 24 hours to healthy volunteers.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-12-01
• Completion: 2015-08-01
• First posted: 2014-01-08
• Last updated: 2017-06-23

Locations

1 site across 1 country: United States