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Dose-dependent Kinetics of Thiamin in Healthy Volunteers With and Without Functional OCT1 Hepatic Transporters

Study acronym: THIAMO-1
StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record status
This record was last updated January 24, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Enrollment target: 24 to 36v3 Show 8 more changesShow less
    • Primary completion date: May 22, 2024 to Jun 30, 2025
    • Primary endpoint revised
    • Trial status: Completed to Enrolling by Invitation
    • Study completion date: May 22, 2024 to Aug 31, 2025
    • Interventions: Thiamin (Dietary Supplement) to Thiamin i.v. (Dietary Supplement), Thiamin p.o. (Dietary Supplement)
    • Secondary endpoints: 6 to 5
    • Study description shortened, about 32 words
    • Study arms: 4 to 5
  2. Trial status: Not Yet Recruiting to Completed
    • Primary and study completion dates changed from estimate of Dec 2024 to May 22, 2024
    • Start date changed from estimate of Nov 20, 2023 to Nov 3, 2023
    • Site contact updated
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study investigates the differences in thiamin (vitamin B1) kinetic parameters in two cohorts of healthy volunteers: Cohort 1) OCT1 wild type genotypes n = 12 Cohort 2) OCT1 deficient genotypes n = 12 Participants will be selected according to their OCT1 genotypes and to achieve best matching according to sex, age, BMI, alcohol consumption, and smoking between Cohort 1 and 2, respectively. The purpose of this study is: 1. To determine the influence of OCT1 genetic variants on dose-dependent thiamin kinetics after oral administration. 2. To elucidate whether OCT1 genetic variants impact the kinetic properties of orally vs. intravenously administered thiamin.
Trial Details
NCT Number NCT06122701
Lead Sponsor University Medicine Greifswald
Conditions
(from sponsor)		 Healthy
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov