MedTrace Logo

A Study Assessing the Mass Balance of a Single Oral Dose of [14C] DS-8500a in Healthy Subjects

NCT02790684 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-02-12

No results posted yet for this study

Summary

This is a Phase 1, open-label, single-center, non-randomized study to assess the mass balance of a single oral dose of DS-8500a in healthy male subjects, 18 years (y) to 60 y of age, inclusive. The radiolabeled investigational medicinal product will be administered to 12 healthy male subjects in 2 cohorts of 6 subjects each.

Conditions

  • Pharmacokinetics

Interventions

DRUG

DS-8500a

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT02790684 on ClinicalTrials.gov