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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: Completed Phase 1 study, sponsored by University of Florida.

NCT02690285 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The TagMan-based genotyping technology will be used for GSTZ1 haplotype analysis from both blood and cheek samples. Haplotype variations in GSTZ1 influence the kinetics of chronically administered investigational medication DCA. The coding region of the GSTZ1 gene contains three functionally important non-synonymous single nucleotide polymorphisms (SNPs) that give rise to five major GSTZ1 haplotypes: KRT (Z1A), KGT (Z1B), EGT (Z1C), EGM (Z1D), and KGM (Z1F).

Interventions

  • DRUG Dichloroacetate (DCA)
  • OTHER GSTZ1 haplotyping

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2016-03-01
Est. Completion 2017-11-01
Phase Phase 1
University of Florida

1,106 total trials

What the finished NCT02690285 record still lists

NCT02690285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 2 interventions - of which Dichloroacetate (DCA) is the first listed.

NCT02690285 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02690285's enrollment target sits among peer trials

45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02690285, the US trial registry maintained by the National Library of Medicine. NCT02690285 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.