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NCT03746106 · ClinicalTrials.gov registry record · Phase 4
The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine
A Phase 4 study of Thiamine Deficiency and Vitamin B1 Deficiency, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT03746106: Completed Phase 4 study of Thiamine Deficiency and Vitamin B1 Deficiency, sponsored by University of California, San Francisco.
NCT03746106 is a Phase 4 study of Thiamine Deficiency and Vitamin B1 Deficiency that has completed, run by University of California, San Francisco. The registered enrollment target is 7 participants, below the 122-participant average among 3 other Thiamine Deficiency trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03746106, a Phase 4 study of Thiamine Deficiency and Vitamin B1 Deficiency, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
In Part 1, subjects will be administered thiamine, thiamine with metformin, and thiamine with trimethoprim. Part 2 will expand on Part 1 and subjects will be administered thiamine and thiamine with trimethoprim. The goal is to determine whether taking a drug and a vitamin together affects the body's ability to absorb, distribute, and eliminate thiamine (Vitamin B1).
Primary Outcome
Plasma samples were collected at pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose for each cycle. Cmax is determined by taking blood samples at various time points after drug administration and analyzing the thiamine concentration in plasma.
Conditions Studied
Interventions
- DRUG Metformin
- DRUG Trimethoprim
- DIETARY_SUPPLEMENT Vitamin B1
Study Locations (1)
Massachusetts
- Jean Mayer USDA Human Nutrition Research Center on Aging - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-01-28 |
| Est. Completion | 2023-08-10 |
| Phase | Phase 4 |
What the finished NCT03746106 record still lists
NCT03746106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 122-participant average among 3 other Thiamine Deficiency trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Thiamine Deficiency appearing as the primary indexed condition, and to 3 interventions - of which Metformin is the first listed.
NCT03746106 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03746106 about?
NCT03746106 is a clinical study titled "The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine". In Part 1, subjects will be administered thiamine, thiamine with metformin, and thiamine with trimethoprim. Part 2 will expand on Part 1 and subjects will be administered thiamine and thiamine with trimethoprim. The goal is to determine whether taking a drug and a vitamin together affects the body's...
What is the current status of trial NCT03746106?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 7 participants. The study started on 2019-01-28. Estimated completion is 2023-08-10.
What conditions does trial NCT03746106 study?
This clinical trial studies the following conditions: Thiamine Deficiency, Vitamin B1 Deficiency.
What interventions are being tested in trial NCT03746106?
The interventions under investigation include: Metformin (DRUG), Trimethoprim (DRUG), Vitamin B1 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03746106?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03746106 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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