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NCT02690285 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of Rapid Haplotyping Procedure for Personalized Dosing of Dichloroacetate (DCA) in Healthy Volunteers
A Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT02690285 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 45 participants.
The verdict
NCT02690285, a Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to identify and analyze the frequency of GSTZ1 haplotypes in a healthy adult population and determine the pharmacokinetics of Dichloroacetate (DCA) metabolism based on haplotype analysis. The DCA drug is the first targeted treatment for Pyruvate Dehydrogenase Complex Deficiency (PDCD). This pilot study, focuses on developing a high throughput, sensitive and accurate screening test for determining glutathione transferase zeta 1 (GSTZ1) haplotype status in individuals who would be treated with DCA.
Interventions
- DRUG Dichloroacetate (DCA)
- OTHER GSTZ1 haplotyping
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2016-03-01 |
| Est. Completion | 2017-11-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02690285
The ClinicalTrials.gov registry entry for NCT02690285 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dichloroacetate (DCA) is the first listed.
NCT02690285 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02690285 about?
NCT02690285 is a clinical study titled "A Pilot Study of Rapid Haplotyping Procedure for Personalized Dosing of Dichloroacetate (DCA) in Healthy Volunteers". The purpose of this study is to identify and analyze the frequency of GSTZ1 haplotypes in a healthy adult population and determine the pharmacokinetics of Dichloroacetate (DCA) metabolism based on haplotype analysis. The DCA drug is the first targeted treatment for Pyruvate Dehydrogenase Complex De...
What is the current status of trial NCT02690285?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2016-03-01. Estimated completion is 2017-11-01.
What interventions are being tested in trial NCT02690285?
The interventions under investigation include: Dichloroacetate (DCA) (DRUG), GSTZ1 haplotyping (OTHER).
Who is sponsoring clinical trial NCT02690285?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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