NCT02844179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

July 20, 2016

Last Update Submit

August 21, 2017

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • VMAT2 occupancy by HTBZ determined by positron emission tomography (PET) scanning

    60 minutes post-administration of HTBZ

Study Arms (1)

dose escalation

EXPERIMENTAL

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

Drug: HTBZ

Interventions

HTBZDRUG
dose escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • able to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan hospitals

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Kirk A Frey, MD, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Radiology

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 26, 2016

Study Start

July 1, 2016

Primary Completion

June 27, 2017

Study Completion

June 27, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

US(1)