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A Pharmacokinetic Study of Oral Deflazacort in Children and Adolescent Subjects With Duchenne Muscular Dystrophy

NCT02251600 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-08-18

No results posted yet for this study

Summary

Study to characterize the single-state and steady-state dosing of oral deflazacort in pediatric and adolescents subjects.

Conditions

Interventions

DRUG

Deflazacort

Oral deflazacort administered once daily at 0.9 mg/kg for eight days

Sponsors & Collaborators

Principal Investigators

  • Katherine Smith, MD · Drug Safety Solutions/Celerion

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT02251600 on ClinicalTrials.gov