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Paid Hepatic Impairment Clinical Trial Now Open at Avail Clinical Research Near Orlando, Florida

Avail is conducting a phase 1, open-label pharmacokinetic and pharmacodynamic study of a single dose of an experimental drug in subjects with hepatic impairment and in matched healthy volunteers.

 
 
Avail Clinical Research
Avail Clinical Research
PRLog - Jun. 10, 2014 - DELAND, Fla. -- To see if you qualify for this Hepatic Impairment Clinical Trial in DeLand (http://www.availclinical.com/trial/hepatitis-c/), visit Avail Clinical Research on the web (http://www.availclinical.com (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.

STUDY DESIGN

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 (http://www.availclinical.com/clinical-trials/hepatitis-c/hepatitis-c-signs-symptoms/) (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 (http://www.availclinical.com/clinical-study/clinical-tria...), 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 (http://www.availclinical.com/news/the-lifecycle-of-hcv-un...). 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.

PRIMARY OBJECTIVES

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.

INCLUSION CRITERIA

All Subjects:

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

Presence of esophageal varices, or

Abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) levels

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 (http://www.availclinical.com/trial/). For more information about participating in a Hepatic Impairment Clinical Trial, please visit our website or contact us directly at (386) 785-2404.

Contact
Jennifer Economou
(386) 785-2404
***@availclinical.com

Photo:
http://www.prlog.org/12334931/1

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Contact Email:
***@availclinical.com Email Verified
Source:Avail Clinical Research
Location:Deland - Florida - United States
Industry:Medical, Research
Tags:hepatic impairment, hepatitis clinical trial, hepatitis clinical research, florida clinical trials, avail clinical research
Shortcut:prlog.org/12334931
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