CompletedPhase 4

The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine

United States7 participantsStarted 2019-01-28

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male or female between the ages of 18-65 years old.
✓. Eats a wide variety of food and willing to consume study diet (i.e. not on a specific diet such as Atkins, Fodmap, etc.).
✓. Written informed consent obtained from the subject and ability for subject to comply with the requirements of the study.

Exclusion criteria

✕. Subjects who are pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
✕. Self-reported severe food allergies or diet restrictions (vegans, vegetarians, Atkins, Fodmap, etc.) that would prevent consumption of study diets.
✕. Subjects with extreme obesity (BMI \> 35).
✕. Subjects who are smokers or have smoked in the past year and/or have smoked or ingested THC/marijuana in the past week, or who are unwilling to comply with a 1-week washout.
✕. Subjects with any disease affecting or impairing the function of the liver, kidney or heart.
✕. Subjects with moderate to severe hypertension.
✕. Subjects with diabetes mellitus, hyperthyroidism, hypothyroidism, cardiovascular disease, glaucoma.
✕. Subjects with gastrointestinal disease, gastrointestinal disorder, or gastrointestinal surgery.

What they're measuring

Maximum Concentration (Cmax) of Thiamine in Plasma Between the Combination Arm(s) and Single Agent Arm

Timeframe: The highest concentration of a thiamine observed in the blood plasma after drug administration

Area Under the Curve From 0 to 24 (AUC0-24)Hours of Thiamine in Plasma Between the Combination Arm(s) and Single Agent Arm

Timeframe: 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.

Trial details

NCT IDNCT03746106

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-10

Results submitted2024-09-09

View on ClinicalTrials.gov More Vitamin B1 Deficiency trials