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NCT02844179 · ClinicalTrials.gov registry record · Phase 1
(+)-Alpha-Dihydrotetrabenazine Phase I
A Phase 1 study of Healthy Subjects, sponsored by Kirk A. Frey.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT02844179: Completed Phase 1 study of Healthy Subjects, sponsored by Kirk A. Frey.
NCT02844179 is a Phase 1 study of Healthy Subjects that has completed, run by Kirk A. Frey. The registered enrollment target is 6 participants, below the 129-participant average among 69 other Healthy Subjects trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02844179, a Phase 1 study of Healthy Subjects, has completed, sponsored by Kirk A. Frey.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG HTBZ
Study Locations (1)
Michigan
- University of Michigan hospitals - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2016-07 |
| Est. Completion | 2017-06-27 |
| Phase | Phase 1 |
What the finished NCT02844179 record still lists
NCT02844179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 129-participant average among 69 other Healthy Subjects trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 1 intervention - of which HTBZ is the first listed.
NCT02844179 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02844179 about?
NCT02844179 is a clinical study titled "(+)-Alpha-Dihydrotetrabenazine Phase I". 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...
What is the current status of trial NCT02844179?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2016-07. Estimated completion is 2017-06-27.
What conditions does trial NCT02844179 study?
This clinical trial studies the following conditions: Healthy Subjects.
What interventions are being tested in trial NCT02844179?
The interventions under investigation include: HTBZ (DRUG).
Who is sponsoring clinical trial NCT02844179?
This trial is sponsored by Kirk A. Frey, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02844179 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02844179's enrollment target sits among peer trials
6 68th of 69 the lowest of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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