(+)-Alpha-Dihydrotetrabenazine Phase I
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- VMAT2 occupancy by HTBZ determined by positron emission tomography (PET) scanning
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •able to provide informed consent
Exclusion Criteria
- •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
Arms & Interventions
dose escalation
Single dose administration of (+)-alpha-Dihydrotetrabenazine (HTBZ), escalating dosage amounts 7.5 - 30 mg orally
Intervention: HTBZ (Drug)
Outcomes
Primary Outcomes
VMAT2 occupancy by HTBZ determined by positron emission tomography (PET) scanning
Time Frame: 60 minutes post-administration of HTBZ
Secondary Outcomes
No secondary outcomes reported
Investigators
Kirk A. Frey
Professor of Radiology
University of Michigan