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Abstract Title:

Safety, tolerability and pharmacokinetics of liposomal curcumin in healthy humans.

Abstract Source:

Int J Clin Pharmacol Ther. 2015 Jan ;53(1):54-65. PMID: 25500488

Abstract Author(s):

Angela Storka, Brigitta Vcelar, Uros Klickovic, Ghazaleh Gouya, Stefan Weisshaar, Stefan Aschauer, Gordon Bolger, Lawrence Helson, Michael Wolzt

Article Affiliation:

Angela Storka

Abstract:

INTRODUCTION: Experimental studies have shown that liposomal curcumin can exert a reduction in tumor growth in pancreatic and colorectal cancer. In this phase I clinical trial we investigated the pharmacokinetics, safety, and tolerability of intravenously administered liposomal curcumin in healthy subjects.

MATERIAL AND METHODS: 50 male and female participants were included in this randomized, placebo-controlled double-blind phase I dose escalation study. Subjects received a single dose of liposomal curcumin (10 - 400 mg/m2; n = 2 - 6 per group) or placebo over 2 hours intravenously.

RESULTS: Dose-dependent increases in the plasma concentrations of curcumin and its metabolite tetrahydrocurcumin (THC) were detected. After the end of drug infusion, curcumin and THC plasma concentrations decreased within 6 - 60 minutes below the limit of quantification. Mean urinary excretion was ~ 0.1% of total systemic clearance. Liposomal curcumin was tolerated well, but a transient red blood cell echinocyte formation with concomitant increase in mean cellular volume was observed at dosages≥ 120 mg/m2.

CONCLUSION: Short-term intravenous dosing of liposomal curcumin appears to be safe up to a dose of 120 mg/m2. Changes in red blood cell morphology may represent a dose limiting sign of toxicity.

Study Type : Human Study

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Sayer Ji
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