Determination of the bioavailability of 14C-hexaminolevulinate using accelerator mass spectrometry after intravesical administration to human volunteers

Klem, B. and Lappin, Graham and Nicholson, S. and Van De Wetering, J. and De Vries, D. E. and Oosterhuis, B. and Garner, R. C. (2006) Determination of the bioavailability of 14C-hexaminolevulinate using accelerator mass spectrometry after intravesical administration to human volunteers. Journal of Clinical Pharmacology, 46 (4). pp. 456-460. ISSN 0091-2700

Full content URL: hhtp://dx.doi.org/10.1177/0091270006286849

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Item Type:Article
Item Status:Live Archive

Abstract

Hexaminolevulinate (HAL) is a diagnostic agent that allows the visualization of tumor tissue in the bladder by fluorescence cystoscopy. It is administered intravesically via a catheter for 1 hour, followed by blue light bladder inspection to induce selective red tumor fluorescence. Hexaminolevulinate should ideally be confined to the bladder only, but it is likely that some absorption occurs during administration, and therefore the systemic bioavailability is of interest. The bioavailability of HAL was determined by intravesical and intravenous administration of 14C-HAL hydrochloride to 8 human volunteers. To reduce the radiation dose as low as possible, the ultrasensitive analytical technique of accelerator mass spectrometry was used to measure 14C-HAL. The bioavailability of 14C-HAL after intravesical and intravenous administration was determined from the respective area under the curve based on total radioactivity and was determined to be 7% (range, 5%-10%; 90% confidence interval). The systemic absorption of 14C-HAL after intravesical administration is low and supports previous clinical experience with HAL showing no systemic side effects. ©2006 the American College of Clinical Pharmacology.

Keywords:aminolevulinic acid hexyl ester, carbon 14, hexaminolevulinate c 14, radiopharmaceutical agent, unclassified drug, 5-aminolevulinic acid hexyl ester, aminolevulinic acid, carbon, drug derivative, photosensitizing agent, absence of side effects, adult, area under the curve, article, confidence interval, drug absorption, drug administration route, drug bioavailability, drug determination, human, human experiment, male, mass spectrometry, normal human, radiation dose, radioactivity, sensitivity analysis, statistical analysis, adolescent, bioavailability, blood, clinical trial, crossover procedure, half life time, intravesical drug administration, middle aged, Administration, Intravesical, Area Under Curve, Biological Availability, Carbon Radioisotopes, Cross-Over Studies, Half-Life, Humans, Middle Aged, Photosensitizing Agents
Subjects:B Subjects allied to Medicine > B210 Pharmacology
Divisions:College of Science > School of Pharmacy
ID Code:8234
Deposited On:24 Mar 2013 15:56

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