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NCT02844179 Clinical Trial

(+)-Alpha-Dihydrotetrabenazine Phase I

Healthy Subjects Clinical Trial

Official title:
(+)-Alpha-Dihydrotetrabenazine Phase I

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02844179
Other study ID # HUM00105810 -1
Secondary ID
Status Completed
Phase Phase 1
First received July 20, 2016
Last updated August 21, 2017
Start date July 2016
Est. completion date June 27, 2017

Study information
Verified date August 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date June 27, 2017
Est. primary completion date June 27, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• HTBZ

Locations
Country Name City State
United States University of Michigan hospitals Ann Arbor Michigan

Sponsors (2)
Lead Sponsor Collaborator
Kirk A. Frey Adeptio Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary VMAT2 occupancy by HTBZ determined by positron emission tomography (PET) scanning 60 minutes post-administration of HTBZ
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