Healthy Subjects
Conditions
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.
Interventions
DRUGHTBZ
Sponsors
Adeptio Pharmaceuticals
Kirk A. Frey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VMAT2 occupancy by HTBZ determined by positron emission tomography (PET) scanning | 60 minutes post-administration of HTBZ |
Countries
United States
Outcome results
None listed