(+)-Alpha-Dihydrotetrabenazine Phase I
- Registration Number
- NCT02844179
- Lead Sponsor
- Kirk A. Frey
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- able to provide informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dose escalation HTBZ Single dose administration of (+)-alpha-Dihydrotetrabenazine (HTBZ), escalating dosage amounts 7.5 - 30 mg orally
- Primary Outcome Measures
Name Time Method VMAT2 occupancy by HTBZ determined by positron emission tomography (PET) scanning 60 minutes post-administration of HTBZ
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Michigan hospitals
🇺🇸Ann Arbor, Michigan, United States