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A Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects

NCT03525405 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-11-08

No results posted yet for this study

Summary

This is a Phase I, single-center, open-label, single-sequence, study evaluating the absorption, metabolism, and excretion of napabucasin in healthy adult male volunteers using a mixture 14C-radiolabeled and unlabeled material.

Conditions

  • ADME
  • Healthy

Interventions

DRUG

napabucasin

Single 240 mg dose containing 100 μCi of 14C-napabucasin will be administered with 240 mL of water following an overnight fast.

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-18
Primary Completion
2018-06-02
Completion
2018-06-02
FDA Drug
Yes

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 NCT03525405 on ClinicalTrials.gov