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

Withdrawn before enrolling · Phase 1

Conditions studied: X-Linked Adrenoleukodystrophy, Adrenomyeloneuropathy

In brief

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.

Key facts

Study ID

NCT01787578

Run by

Thomas S. Scanlan

People needed

0

Starts

2013-04-01

Expected to finish

2014-02-01

Last updated by the study team

2014-02-14

Who can join

Age: 18 and older, up to 64. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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