DeLand, FL (PRWEB) June 10, 2014
To see if you qualify for this Hepatic Impairment Clinical Trial in DeLand, visit Avail Clinical Research on the web (http://www.availclinical.com) or contact us directly at (386) 785-2404. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of a new hepatic function drug following a single 50 mg oral dose of the medication in subjects with mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C, respectively) and matched healthy volunteers with normal hepatic function. Depending on the data from the 50 mg dose groups, a lower dose of this medication may be studied in additional groups of subjects with hepatic impairment.
BACKGROUND & RATIONALE
This clinical study is being undertaken to evaluate the pharmacokinetics of a single 50 mg dose of an experimental medication in subjects with hepatic impairment (defined as Child-Pugh A, B, and C, respectively) compared to matched healthy volunteers, with the option to study a lower dose of this new drug in subjects with hepatic impairment based on emerging data. The data from this study will help inform researchers of the safety of this new medication in subjects with hepatic impairment, and address whether dose adjustment is required in this subject population.
Researchers intend to pursue studies in subjects with acute and chronic liver disease. It is anticipated that the data obtained from this study will allow them to expand the study population in future, and possibly, in ongoing studies to include those with severe hepatic impairment.
To assess the pharmacokinetics and pharmacodynamics of a single oral dose of this new drug in subjects with hepatic impairment compared to that in matched healthy volunteers.
To assess the safety and tolerability of the experimental medication in subjects with hepatic impairment.
Matched Healthy Volunteers:
Subjects with Hepatic Impairment: