HealthyTHIAMO-1NCT06122701
Dose-dependent Kinetics of Thiamin in Healthy Volunteers With and Without Functional OCT1 Hepatic Transporters
A study testing Thiamin p.o. and Thiamin i.v. in people with Healthy, run by University Medicine Greifswald at 1 site in Germany.
Trial 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 = 12 Participants will be selected according to their OCT1 genotypes and to achieve best matching according to sex… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Thiamin p.o. and Thiamin i.v.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 3 Nov 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Medicine Greifswald, Institute of Pharmacology
Greifswald, Mecklenburg-Vorpommern, 17489
About this study
Official title: Cross-over Randomized Study to Determine Dose-dependent Kinetics of Thiamin in Healthy Volunteers With and Without Functional OCT1 Hepatic Transporters
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:
- To determine the influence of OCT1 genetic variants on dose-dependent thiamin kinetics after oral administration.
- To elucidate whether OCT1 genetic variants impact the kinetic properties of orally vs. intravenously administered thiamin.
Read the 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 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. These four arms will be put into practice at the same time with each participant completing all four arms in random order with a wash-out period of at least one week between each arm.
After analyzing the four oral arms, we decided to administer a single i.v. dose of 5 mg thiamin in arm 5.
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. At baseline, 2x 2.7 ml EDTA blood samples will be collected for DNA isolation if the particular volunteer has not had a genotypical validation in another study of our Institute.
The total amount of blood collected for each participant is 456 ml at eight kinetic visits and 10 ml at the Screening.
After intake of the thiamin solution, participants will drink 100 ml of sparkling water every hour to stimulate gastrointestinal peristalsis. After 4 hours the participants will be served a meal low in thiamin content. Urine will be collected during the first 10 hours after thiamin administration. Monitoring of blood pressure and heart rate will take place for the first 4 hours after administration. Volunteers will stay in the Clinical Research Unit of the Institute of Pharmacology for the first 10 hours after administration.
- Conditions
- Healthy
- Being tested
- Thiamin p.o., Thiamin i.v.
- Keywords
- Thiamin, Vitamin B1, OCT1, kinetic parameters, dose-dependency, genotypes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiamin p.o.Dietary supplement
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.
Thiamin i.v.Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| OCT1 deficient and wild type genotypes: 200 mg thiamin p.o. | Active comparator | The participants are selected to achieve best matching according to sex, age, BMI, alcohol consumption and smoking between cohort 1 and cohort 2. Receives: Dietary Supplement: Thiamin p.o. |
| OCT1 deficient and wild type genotypes: 50 mg thiamin p.o. | Active comparator | The participants are selected to achieve best matching according to sex, age, BMI, alcohol consumption and smoking between cohort 1 and cohort 2. Receives: Dietary Supplement: Thiamin p.o. |
| OCT1 deficient and wild type genotypes: 10 mg thiamin p.o. | Active comparator | The participants are selected to achieve best matching according to sex, age, BMI, alcohol consumption and smoking between cohort 1 and cohort 2. Receives: Dietary Supplement: Thiamin p.o. |
| OCT1 deficient and wild type genotypes: 5 mg thiamin p.o. | Active comparator | The participants are selected to achieve best matching according to sex, age, BMI, alcohol consumption and smoking between cohort 1 and cohort 2. Receives: Dietary Supplement: Thiamin p.o. |
| OCT1 deficient and wild type genotypes: 5 mg thiamin i.v. | Active comparator | The participants are selected to achieve best matching according to sex, age, BMI, alcohol consumption and smoking between cohort 1 and cohort 2. Receives: Dietary Supplement: Thiamin i.v. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thiamin plasma concentrations expressed as Area under the Curve (AUC0-24 hours)
Difference in thiamin plasma concentrations expressed as Area under the Curve (AUC0-24 hours) between OCT1 wild type and OCT1 deficiency cohorts (Cohort 1 vs. Cohort 2) in each dose arm
Measured: 24 hours
Secondary outcomes (5)
Cmax of thiamin and its phosphorylated esters, TMP and TDP
Differences in Cmax of thiamin and its phosphorylated esters, TMP and TDP, between the above-described cohorts in each dose arm
Measured: 24 hours
Tmax of thiamin and its phosphorylated esters, TMP and TDP
Differences in Tmax of thiamin and its phosphorylated esters, TMP and TDP, between the above-described cohorts in each dose arm
Measured: 24 hours
Total and renal clearance of thiamin and its phosphorylated esters, TMP and TDP
Differences in total and renal clearance of thiamin and its phosphorylated esters, TMP and TDP, between the above-described cohorts in each dose arm
Measured: 24 hours
Apparent volume of distribution of thiamin and its phosphorylated esters, TMP and TDP
Differences in the apparent volume of distribution of thiamin and its phosphorylated esters, TMP and TDP, between the above-described cohorts in each dose arm
Measured: 24 hours
Plasma concentrations of known endogenous biomarkers such as isobutyrylcarnitine and propionylcarnitine
Changes in plasma concentrations of known endogenous biomarkers such as isobutyrylcarnitine and propionylcarnitine measured at all time points following thiamin administration
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start3 Nov 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model 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) and a single i.v. dose (5 mg).
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Engeli, MD, University Medicine Greifswald
- Investigators
- Stefan Engeli, Principal investigator, Universitätsmedizin Greifswald, Institut für Pharmakologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122701
- Sponsor's protocol ID
- IPHA-2023-007
- Acronym
- THIAMO-1
- Status last verified
- Jan 2025
- First submitted
- 1 Nov 2023
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-over Randomized Study to Determine Dose-dependent Kinetics of Thiamin in Healthy Volunteers With and Without Functional OCT1 Hepatic Transporters
- ClinicalTrials.gov ID
- NCT06122701
- Acronym / sponsor ID
- THIAMO-1 / IPHA-2023-007
- Conditions
- Healthy
- Keywords
- Thiamin, Vitamin B1, OCT1, kinetic parameters, dose-dependency, genotypes
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the influence of OCT1 genetic variants on dose-dependent thiamin kinetics after oral administration.
- To elucidate whether OCT1 genetic variants impact the kinetic properties of orally vs. intravenously administered thiamin.
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 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. These four arms will be put into practice at the same time with each participant completing all four arms in random order with a wash-out period of at least one week between each arm.
After analyzing the four oral arms, we decided to administer a single i.v. dose of 5 mg thiamin in arm 5.
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. At baseline, 2x 2.7 ml EDTA blood samples will be collected for DNA isolation if the particular volunteer has not had a genotypical validation in another study of our Institute.
The total amount of blood collected for each participant is 456 ml at eight kinetic visits and 10 ml at the Screening.
After intake of the thiamin solution, participants will drink 100 ml of sparkling water every hour to stimulate gastrointestinal peristalsis. After 4 hours the participants will be served a meal low in thiamin content. Urine will be collected during the first 10 hours after thiamin administration. Monitoring of blood pressure and heart rate will take place for the first 4 hours after administration. Volunteers will stay in the Clinical Research Unit of the Institute of Pharmacology for the first 10 hours after administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model 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) and a single i.v. dose (5 mg).
| Arm | Type | Receives |
|---|---|---|
| OCT1 deficient and wild type genotypes: 200 mg thiamin p.o. | Active comparator | Dietary Supplement: Thiamin p.o.The participants are selected to achieve best matching according to sex, age, BMI, alcohol consumption and smoking between cohort 1 and cohort 2. |
| OCT1 deficient and wild type genotypes: 50 mg thiamin p.o. | Active comparator | Dietary Supplement: Thiamin p.o.The participants are selected to achieve best matching according to sex, age, BMI, alcohol consumption and smoking between cohort 1 and cohort 2. |
| OCT1 deficient and wild type genotypes: 10 mg thiamin p.o. | Active comparator | Dietary Supplement: Thiamin p.o.The participants are selected to achieve best matching according to sex, age, BMI, alcohol consumption and smoking between cohort 1 and cohort 2. |
| OCT1 deficient and wild type genotypes: 5 mg thiamin p.o. | Active comparator | Dietary Supplement: Thiamin p.o.The participants are selected to achieve best matching according to sex, age, BMI, alcohol consumption and smoking between cohort 1 and cohort 2. |
| OCT1 deficient and wild type genotypes: 5 mg thiamin i.v. | Active comparator | Dietary Supplement: Thiamin i.v.The participants are selected to achieve best matching according to sex, age, BMI, alcohol consumption and smoking between cohort 1 and cohort 2. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | OCT1 deficient and wild type genotypes: 10 mg thiamin p.o., OCT1 deficient and wild type genotypes: 200 mg thiamin p.o., OCT1 deficient and wild type genotypes: 5 mg thiamin p.o., OCT1 deficient and wild type genotypes: 50 mg thiamin p.o. |
| 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. | Dietary supplement | OCT1 deficient and wild type genotypes: 5 mg thiamin i.v. |
Primary outcome
Thiamin plasma concentrations expressed as Area under the Curve (AUC0-24 hours)
Time frame: 24 hours
Difference in thiamin plasma concentrations expressed as Area under the Curve (AUC0-24 hours) between OCT1 wild type and OCT1 deficiency cohorts (Cohort 1 vs. Cohort 2) in each dose arm
5 secondary outcomes
Cmax of thiamin and its phosphorylated esters, TMP and TDP
Time frame: 24 hours
Tmax of thiamin and its phosphorylated esters, TMP and TDP
Time frame: 24 hours
Total and renal clearance of thiamin and its phosphorylated esters, TMP and TDP
Time frame: 24 hours
Apparent volume of distribution of thiamin and its phosphorylated esters, TMP and TDP
Time frame: 24 hours
Plasma concentrations of known endogenous biomarkers such as isobutyrylcarnitine and propionylcarnitine
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Engeli principal investigator
Universitätsmedizin Greifswald, Institut für Pharmakologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thiamin p.o. and Thiamin i.v. in people with Healthy, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thiamin plasma concentrations expressed as Area under the Curve (AUC0-24 hours) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.