(+)-Alpha-Dihydrotetrabenazine Phase I

Kirk A. Frey

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: HTBZ

Study type: Interventional

Funder types: Other

Identifiers

NCT02844179

HUM00105810 -1

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

dose escalation

Experimental group

Description:

Single dose administration of (+)-alpha-Dihydrotetrabenazine (HTBZ), escalating dosage amounts 7.5 - 30 mg orally

Treatment:

Drug: HTBZ