Phase 4
N=7
The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine
Vitamin B1 Deficiency · Thiamine Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT03746106 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Maximum Concentration (Cmax) of Thiamine in Plasma Between the Combination Arm(s) and Single Agent Arm — 15; 32 nM
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Trimethoprim (Drug); Metformin (Drug); Vitamin B1 (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Concentration (Cmax) of Thiamine in Plasma Between the Combination Arm(s) and Single Agent Arm |
15; 32 | — |
| PRIMARY Area Under the Curve From 0 to 24 (AUC0-24)Hours of Thiamine in Plasma Between the Combination Arm(s) and Single Agent Arm |
50; 189 | — |
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).
Eligibility Criteria
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.
- Subjects with known infection with HIV, Hepatitis B (HBsAg) or Hepatitis C (no laboratory diagnostics concerning these diseases will be performed within the present study. Volunteers who are cured of past HepC infection are eligible to participate with doctor's approval letter).
- Alcohol use on average > 2 servings/day or > 14 servings/wk (Serving size: 12oz beer/4oz wine/2oz hard liquor) or self-reported binge drinking.
- Subjects that are on vitamin B supplements or multi-vitamins or who have taken vitamin B supplements or multi-vitamins in the past 30 days, or are not willing to comply with a 30-day washout of vitamin B supplements.
- Subjects with possible folate deficiency.
- Subjects taking any other clinically significant drugs as judged by the investigator.
- Subjects with a condition, disease, or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Female subjects undergoing treatment for infertility or hormone replacement therapy (Volunteers using hormonal birth control will not be excluded).
- Subjects who have taken antimalarials in the past 60 days.
- Participating in another research study while participating in this research study.
- Non-English speaking
- Subjects with abnormal laboratory results at screening as judged by the investigator or study physician.
Data sourced from ClinicalTrials.gov (NCT03746106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.