Trial reportEuropean journal of clinical pharmacology2026
Further elucidation on the effect of food on the pharmacokinetics of trientine.
Trial report in European journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeTrientine dihydrochloride (TETA-2HCl) – a copper-selective chelator that forms a stable soluble complex with copper (Cu) and promotes excretion of this complex via the urine – is used as a treatment in Wilson Disease (WD) patients who are intolerant to D-penicillamine. Although in clinical practice patients are instructed to take TETA-2HCl on an empty stomach at least one hour before meals or two hours after meals, the effect of food on the pharmacokinetics of TETA-2HCl has not previously been systematically investigated in humans.
methodsIn this open-label, single dose, randomized, two period cross-over study in healthy adults, a single oral dose of 600 mg of TETA-2HCl (2 × 300 mg capsules) was once administered under fed and once under fasted conditions with a wash-out period of at least one week. Blood samples were collected for up to 48 h after each dosing for analysis of plasma trientine (TETA) and its metabolites N1-acetyltriethylenetetramine (MAT) and N1-N10-diacetyltriethylenetetramine (DAT).
resultsFood had a significant effect on the pharmacokinetics of TETA and its metabolites MAT and DAT. Maximum plasma concentrations, and the exposures of TETA are significantly reduced by food (Cmax: 45%, AUC0 − t and AUC0 − inf: 44%.). Similar effects were seen for the metabolites MAT and DAT. The tolerability of treatment with TETA-2HCl was not affected by the intake of food.
conclusionThe study shows a significant impact of food on the pharmacokinetics of TETA, supporting the current instruction on administration of TETA-2HCl on an empty stomach in clinical practice. ClinicalTrials.gov Identifier: EudraCT number: 2018-001982-17. Date registered: 16 May 2018.
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