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Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Adrenoleukodystrophy

NCT03196765 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2019-03-07

No results posted yet for this study

Summary

This is a phase I/II, open label dose escalation study of multiple dose levels of NV1205 with a long-term treatment phase.

Conditions

  • X-Linked Adrenoleukodystrophy

Interventions

DRUG

Sobetirome (NV1205)

Once a day oral dose of the study drug

Sponsors & Collaborators

  • NeuroVia, Inc.

    lead INDUSTRY

Principal Investigators

  • John Henderson, MD · NeuroVia, Inc.

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2020-12-01
Completion
2020-12-01
FDA Drug
Yes

Countries

  • Argentina
  • Australia
  • Chile
  • Colombia
  • France
  • Russia
  • Ukraine
  • United Kingdom

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 NCT03196765 on ClinicalTrials.gov