Hepatic Insufficiency Clinical Trial
Official title:
Pharmacokinetics of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients
This study aims to investigate whether liver patients may tolerate alitretinoin by comparing metabolism in 8 such patients with the metabolism in 8 healthy controls
This study aims to investigate whether liver patients may tolerate alitretinoin.
Toctino (alitretinoin) is a vitamin A like substance that has proven effective in the
treatment of specially hand eczema. The medicine is taken as capsules daily for up to 3
months. Toctino is currently only approved for patients with normal liver function, because
it has never been studied how drug metabolism and excretion occurs in liver disease
patients. This, however, the investigators want to examine in order to achieve an additional
treatment for patients with severe hand eczema and concomitant liver disease.
The study is a collaboration between dermatology and medical department, Gentofte Hospital
and University of Copenhagen, where blood and urine tests will be conducted. From the
medical department, 8 patients diagnosed with liver disease will be recruited. Patients
should only receive a single dose of Toctino (30 mg capsules). 20 blood samples and one
urine sample will be taken over the next 24 hours (approximately 250-300 ml) to measure the
concentration of Toctino in blood and urine. Moreover, the urine will be collected over 24
hours. Then the investigators will recruit an 8-person control group that is matched
according to gender, age and weight. In this control group will take exactly the same
samples. Based on determining concentrations in blood and urine will be able to
mathematically calculate how Toctino is absorbed, distributed and excreted in liver disease
patients in conjunction with a healthy control group. The study will therefore help to
determine what dose of Toctino that would be preferable in liver disease patients.
The survey is estimated to be associated with a very low risk both for participating
patients and control group. Toctino is an approved drug and side effects occur almost
exclusively in long term treatment.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
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