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

NCT02030639 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-06-23

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Traws Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Francois Wilhelm, MD, PhD · Traws Pharma, Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-12-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02030639 on ClinicalTrials.gov