A Pilot Study of Rapid Haplotyping Procedure for Personalized Dosing of Dichloroacetate (DCA) in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02690285

Run by

University of Florida

People needed

45

Starts

2016-03-01

Expected to finish

2017-11-01

Last updated by the study team

2018-12-31

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy as outline in the physical exam and blood tests
• Non smoker

You may not qualify if…

• Cannot comprehend or refuse to sign the informed consent form;
• Febrile or have other clinical signs of infection;
• Pregnant or are nursing;
• In females, cannot or refuse to use contraception or avoid unprotected intercourse during the study;
• Uncontrolled hypertension (BPs > 160 mmHg or BPd > 100 mmHg) on conventional medication;
• Anemic (hematocrit < 35% in males; < 35% in females;
• Serum creatinine ≥ 1.3 mg/dl, TSH > 4.5 mIU/ml; a transaminase (ALT or AST) > 2 x ULN, total bilirubin > 1.2 mg/dl or fasting glucose ≥ 110 mg/dl.
• History of psychosis, seizures or diabetes mellitus or be receiving anti-psychotic, anti-epileptic or blood glucose-lowering medication.

Where it is running

• UF Health: Clinical Research Center — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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