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Follow on Google News | Paid Hepatic Impairment Clinical Trial Now Open at Avail Clinical Research Near Orlando, FloridaAvail 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.
By: Avail Clinical Research 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/ 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) Researchers intend to pursue studies in subjects with acute and chronic liver disease (http://www.availclinical.com/ 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/ End
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