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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 3, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

August 31, 2025

Conditions
Healthy
Interventions
DIETARY_SUPPLEMENT

Thiamin p.o.

"A single oral dose of thiamin will be administered in four intervention arms (arm 1: 200 mg, arm 2: 50 mg, arm 3: 10 mg, arm 4: 5 mg) as a drinking solution with 240 ml of still water after an overnight fast.~A total of 15 blood samples will be taken at defined time points (baseline; 0.25; 0.5; 0.75; 1.0; 1.5; 2.0; 2.5; 3.0; 3.5; 4.0; 6.0; 8.0; 10.0; 24.0 h). At each time point, blood will be collected (4.9 ml for plasma and 2.7 ml for whole blood) to determine thiamin, TMP and TDP, and biomarkers of OCT1 transport activity. Urine will be collected during the first 10 hours after thiamin administration."

DIETARY_SUPPLEMENT

Thiamin i.v.

"A single i.v. dose of thiamin 5 mg with 240 ml of still water after an overnight fast.~A total of 15 blood samples will be taken at defined time points (baseline; 0.25; 0.5; 0.75; 1.0; 1.5; 2.0; 2.5; 3.0; 3.5; 4.0; 6.0; 8.0; 10.0; 24.0 h). At each time point, blood will be collected (4.9 ml for plasma and 2.7 ml for whole blood) to determine thiamin, TMP and TDP, and biomarkers of OCT1 transport activity. Urine will be collected during the first 10 hours after thiamin administration."

Trial Locations (1)

17489

University Medicine Greifswald, Institute of Pharmacology, Greifswald

All Listed Sponsors
lead

University Medicine Greifswald

OTHER