drugset / Trial / NCT01467258

Urinary Excretion of Acetylamantadine by Normal Healthy Volunteers

NCT01467258

NaSingle-groupOpen-labelDiagnostic

Summary

Amantadine appears to be a specific substrate for acetylation by spermidine/spermine N1-acetyltransferase (SSAT). SSAT activity in cancer cells is higher by several-fold compared to normal cells. Amantadine can be used to determine SSAT cellular activity, and may indicate the presence of cancer. This study will provide additional information in conjunction with data from a previous study which include cancer patients and normal health age matched controls to determine whether urinary excretion of acetylamantadine is predictive for the presence of cancer, and if so whether excretion of this metabolite is associated with any particular site of the tumor. Based on the results of the first study additional data in normal healthy volunteers is required. The data from both studies will be analyzed to account for subject gender, stage of disease at time of testing, concurrent diseases, alcohol and tobacco use and occupational characteristics. This is an important first step in validating a cancer detection method that can be implemented economically for screening of large numbers of people at sites remote from limited and expensive diagnostic instrumentation. Thus there is a possibility that this design can be prognosis biomarker as well as a positive/negative indicator.

Timeline

Start
2011-11
Primary completion
2012-04
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Amantadine Unknown 200 mg

Indications

No indication recorded.