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 tomatched 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.
Male or female subjects 18 years of age or older, able to provide written informed consent, understand and comply with all scheduled visits, and other requirements of the study
Body mass index (BMI) 18.0 – 40.0 kg/m2 and body weight greater than 45 kg
Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug
Matched Healthy Volunteers:
Medically healthy as determined by the Investigator
Supine blood pressure less than or equal to 145/90 mmHg
No significant uncontrolled systemic or major illness that, in the opinion of the
Investigator, would preclude the subject from participating in and completing the study
Demographically comparable to subjects with hepatic impairment as follows:
Mean body weight within ±15 kg
Mean age within ±10 years
Similar gender ratio
Subjects with Hepatic Impairment:
Evidence of hepatic disease:
Score greater than or equal to 2 on one of the Child-Pugh parameters, or
Histological or imaging diagnosis of cirrhosis, or
Meet one of the following criteria for Child-Pugh classification for hepatic impairment during Screening:
Mild hepatic impairment: Class A (Child-Pugh Scores 5-6 points)
Moderate hepatic impairment: Class B (Child-Pugh Scores 7-9 points)
Severe hepatic impairment: Class C (Child Pugh Scores 10-15 points)
Supine blood pressure less than or equal to 160/100 mmHg
Avail Clinical Research conducts a variety of Clinical Research Studies in Florida. For more information about participating in a Hepatic Impairment Clinical Trial, please visit their website or contact them directly at (386) 785-2404.
Press Contact: Jennifer Economou 860 Peachwood Dr.
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