Status:
ENROLLING_BY_INVITATION
Dose-dependent Kinetics of Thiamin in Healthy Volunteers With and Without Functional OCT1 Hepatic Transporters
Lead Sponsor:
University Medicine Greifswald
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
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...
Detailed Description
The study is designed as a 5-arm cross-over, open-label, randomized single oral dose comparison (5 mg, 10 mg, 50 mg, and 200 mg thiamin). A fifth arm includes applying 5 mg thiamin intravenously. A s...
Eligibility Criteria
Inclusion
- any sex
- age between 18 and 50 years
- OCT1 wild type: homozygous for OCT1\*1 OCT "poor transporter": homozygous or heterozygous for OCT1\*3, \*4, \*5, \*6
- understands the study purpose and design
- contractually capable and provides signed informed consent form
- healthy condition or mild and/or well-treated forms of allergies, asthma, hypertension, and orthopedic diseases
- a maximum of 3 chronically taken drugs not interfering with OCT1 activity
Exclusion
- BMI \> 32 kg/m2 and \< 17 kg/m2
- body weight \< 48 kg
- known pregnancy or lactation period
- women: positive urine pregnancy test at screening or kinetic visit 1 of each arm
- men: hemoglobin \< 13 g/dl (8,07 mmol/l) women: hemoglobin \< 12 g/dl (7,45 mmol/l)
- elevated liver function tests (1 or more of ALAT, ASAT, yGT, Bilirubin \> 2x ULN)
- reduced renal function (eGFRMDRD \< 60 ml/min/1,7 m2)
- QTcF \> 450 ms in screening ECG
- psychiatric disease requiring recent or actual treatment
- drug dependency at the time of visit
- use of recreational drugs more than twice a week
- any known hypersensitivity or allergic reactions to thiamin
- history of severe hypersensitivity reactions and/or anaphylaxis
- clinically proven vitamin B1 deficiency
- individuals taking regular vitamin B1 or multi-vitamin supplements who are not willing to comply with a 48-hour washout of these supplements before each kinetic visit
- individuals who have taken vitamin B supplements or multi-vitamins in the past 2 days before kinetic visit 1 of each arm
- poor venous conditions that make it impossible to place a peripheral venous catheter and regularly draw blood through it
Key Trial Info
Start Date :
November 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06122701
Start Date
November 3 2023
End Date
August 31 2025
Last Update
January 24 2025
Active Locations (1)
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1
University Medicine Greifswald, Institute of Pharmacology
Greifswald, Mecklenburg-Vorpommern, Germany, 17489