Clinical TrialID 6680

The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine

NCT03746106

Vitamin B1 Deficiency|Thiamine Deficiency

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
6680
Evidence Id
6680
Core Evidence Id
6680
Source Clinical Trial Id
6666
Herb2 Clinical Trial Id
HBCT006666
Nct Id
NCT03746106
Title
The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine
Status
Completed
Phase
Phase 4
Study Result
No
Study Condition
Vitamin B1 Deficiency|Thiamine Deficiency
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Intervention
DRUG: Trimethoprim|DRUG: Metformin|DIETARY_SUPPLEMENT: Vitamin B1
Intervention Allocation
Randomized
Intervention Model
Crossover
Intervention Mask
Intervention Purpose
Basic_Science
Gender
All
Age
Adult, Older_Adult
Enrollment
7
Outcome Measure
Area Under the Concentration-Time Curve (AUC 0-72h), Blood samples were obtained and plasma concentrations were determined using a validated high-pressure liquid chromatography method., As determined by blood/urine levels taken over the course of 2-3 cycles (each cycle is 3 days with a 5-14 day washout in between cycles)|Assess the effects of SLC19A3 inhibitors by Cmax, In Parts 1 and 2, assess the effects of SLC19A3 inhibitors on the absorption and distribution of thiamine as measured by the change in maximum concentration (Cmax) between the combination arm(s) and single agent arm., As determined by blood/urine levels taken over the course of 2-3 cycles (each cycle is 3 days with a 5-14 day washout in between cycles)
Sponsor Collaborator
University of California, San Francisco|Tufts University|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|University of California, Davis
Funded By
OTHER
Location
Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, Massachusetts, 02111, United States
Other Id
13060|5R01DK108722-02
Start Date
2019-01-28
Primary Completion Date
2023-08-10
Completion Date
2023-08-10
First Posted
2018-11-19
Results First Posted
Last Update Posted
2023-08-14
Study Document
Study Url
https://clinicaltrials.gov/study/NCT03746106
Title Cn
Title En
The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine
Bilingual Status
semi_complete