## Protocol Section
### Identification Module
**NCT ID:** NCT02844179

**Brief Title:** (+)-Alpha-Dihydrotetrabenazine Phase I

**Official Title:** (+)-Alpha-Dihydrotetrabenazine Phase I

#### Organization Study ID Info
**ID:** HUM00105810 -1
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2017-06-27

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-08-22

**Type:** ACTUAL

**Last Update Submit Date:** 2017-08-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-06-27

**Type:** ACTUAL

#### Start Date
**Date:** 2016-07

**Status Verified Date:** 2017-08

#### Study First Post Date
**Date:** 2016-07-26
**Type:** ESTIMATED
**Study First Submit Date:** 2016-07-20
**Study First Submit QC Date:** 2016-07-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Adeptio Pharmaceuticals

#### Lead Sponsor

**Class:** OTHER

**Name:** Kirk A. Frey

#### Responsible Party

**Investigator Affiliation:** University of Michigan

**Investigator Full Name:** Kirk A. Frey

**Investigator Title:** Professor of Radiology

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Healthy Subjects

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 6

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: HTBZ

**Label:** dose escalation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- dose escalation

**Name:** HTBZ

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** VMAT2 occupancy by HTBZ determined by positron emission tomography (PET) scanning

**Time Frame:** 60 minutes post-administration of HTBZ

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ann Arbor

**Country:** United States

**Facility:** University of Michigan hospitals

**State:** Michigan

**Zip:** 48109

#### Overall Officials

**Official 1:**

**Affiliation:** University of Michigan

**Name:** Kirk A Frey, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
