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The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine

NCT03746106 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-01-03

Study results available
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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).

Conditions

  • Vitamin B1 Deficiency
  • Thiamine Deficiency

Interventions

DRUG

Trimethoprim

300mg of trimethoprim will be given in combination with 5mg thiamine and compared to 5mg thiamine only for both Parts 1 and 2 of the study.

DRUG

Metformin

1000mg of metformin will be given in combination with 5mg thiamine and compared to 5mg thiamine only in Part 1 of the study.

DIETARY_SUPPLEMENT

Vitamin B1

5mg of thiamine will be given alone and in combination for both Parts 1 and 2 of the study.

Sponsors & Collaborators

  • Tufts University

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of California, Davis

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Kathleen M Giacomini · University of California, San Francisco

  • Andrew S Greenberg · Tufts University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2023-08-10
Completion
2023-08-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03746106 on ClinicalTrials.gov