Safety and Pharmacodynamic Study of Sobetirome in X-Linked Adrenoleukodystrophy (X-ALD)

• Status: Withdrawn
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess the safety, tolerance, pharmacokinetics, and pharmacodynamics of sobetirome, a selective thyroid hormone analog, in adult male X-ALD patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas S. Scanlan

Criteria

Inclusion Criteria:

• males 18-65 years old

• X-ALD diagnosis by either elevated VLCFAs or DNA testing

• must sign informed consent and agree to complete required clinic visits.

Exclusion Criteria:

• female gender

• abnormal laboratory test results (except VLCFA) at screening visit

• history of coronary artery disease

• use of triiodothyronine therapy

• abnormal thyroid function test at screening visit

• untreated adrenal insufficiency

• currently taking Lorenzo's Oil or other VLCFA lowering agent

• participation in investigational drug study within 30 days