(+)-Alpha-Dihydrotetrabenazine Phase I

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

This research study is intended to determine the initial safety and tolerability of single oral doses of the drug (+)-alpha-dihydrotetrabenaxine (HTBZ) in normal volunteers. HTBZ is believed to be the active ingredient in the FDA-approved drug tetrabenazine (TBZ, brand name Xenazine), prescribed for treatment of involuntary movements in patients with Huntington's chorea. TBZ is a mixture of closely-related compounds (isomers) and is readily metabolized (converted) in the human body to HTBZ and related isomers. Investigators believe that HTBZ, the drug to be studied in this research, is the active ingredient in TBZ. The present study will confirm safety and tolerability of HTBZ and will investigate its expected effects on brain sites that are the target of TBZ therapy.

Key facts

Study ID

NCT02844179

Run by

Kirk A. Frey

People needed

6

Starts

2016-07-01

Expected to finish

2017-06-27

Last updated by the study team

2017-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• able to provide informed consent

You may not qualify if…

• pregnant or lactating female subjects
• Subjects taking medications that interfere with VMAT2 (ex amphetamine)
• History of significant neurologic or psychiatric conditions
• Significant active medical conditions
• Alcohol or illicit substance use or dependence

Where it is running

• University of Michigan hospitals — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.