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Phase 4 N=7 Randomized Basic Science

The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine

Vitamin B1 Deficiency · Thiamine Deficiency

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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