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SLC19A3 Inhibitor
Trimethporim + thiamine combination for Beriberi
Phase 4
Waitlist Available
Led By Kathleen M Giacomini
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up as determined by blood/urine levels taken over the course of 2-3 cycles (each cycle is 3 days with a 5-14 day washout in between cycles)
Awards & highlights
Study Summary
This trial will explore if taking a drug and a vitamin together affects how the body uses Vitamin B1.
Eligible Conditions
- Beriberi
- Thiamine Deficiency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ as determined by blood/urine levels taken over the course of 2-3 cycles (each cycle is 3 days with a 5-14 day washout in between cycles)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~as determined by blood/urine levels taken over the course of 2-3 cycles (each cycle is 3 days with a 5-14 day washout in between cycles)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under the Concentration-Time Curve (AUC 0-72h)
Assess the effects of SLC19A3 inhibitors by Cmax
Secondary outcome measures
Determine the effect of genetic variants of thiamine transporters
Investigate metabolic signatures reflecting the activity of TPP-dependent enzymes
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Trimethporim + thiamine combinationExperimental Treatment2 Interventions
5mg thiamine tablet and 300mg trimethoprim tablet by mouth. This arm will be included in both Parts 1 and 2 of the study.
Group II: Metformin + thiamine combinationExperimental Treatment2 Interventions
5mg thiamine tablet and 1000mg metformin tablet by mouth. This arm will be included in only Part 1 of the study.
Group III: Thiamine onlyActive Control1 Intervention
5mg thiamine tablet by mouth. This arm will be included in both Parts 1 and 2 of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin B1
2018
Completed Phase 4
~200
Trimethoprim
FDA approved
Thiamine
FDA approved
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,525 Previous Clinical Trials
15,243,618 Total Patients Enrolled
Tufts UniversityOTHER
268 Previous Clinical Trials
596,818 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,315,555 Total Patients Enrolled
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