Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects

Exclusion Criteria

• •Medical conditions: (a) pregnancy; and (b) breastfeeding
• •Psychiatric conditions: (a) current treatment for opioid addiction with substitution therapies; (b) active history of bipolar I, bipolar II, schizophrenia, schizophreniform; schizoaffective; mania, hypomania, or severe post-traumatic stress disorder; and (c) presence of suicidal behavior within the year before informed consent or suicidal intent within the 30 days before informed consent as documented by the Columbia Suicide Severity Rating Scale
• •Hypersensitivity to opioids, defined as intractable vomiting, severe constipation, or severe pruritus after opioid treatment
• •Subject has a known intolerance or hypersensitivity to buprenorphine or naloxone or any excipients in the Suboxone tablet formulation
• •In the judgment of the investigator, any other condition that would preclude safe, useful, or consistent participation in the study
• •Use of any investigational medication or investigational medical device in the 30 days before informed consent
• •Hepatic encephalopathy greater than West Haven Grade 2
• •Donation of \> 250 ml of blood within previous 30 days
• •Systolic BP ≤ 90 or ≥ 160 mmHg and/or Diastolic BP \< 60 mmHg or \> 100 mmHg
• •History of cholecystectomy
• •History or current acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) antibodies
• •Estimated creatinine clearance rate (eC Cr) using Cockcroft-Gault formula \< 60 mL/min
• •More than 1 missed appointment during Screening
• •Currently under mandate by the criminal justice system or Child and Family Services to participate in drug abuse treatment
• •Participation in drug or alcohol dependence treatment in the 30 days before informed consent
• •Positive urine drug screen result for amphetamines, methamphetamine, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine, methadone, opioids, oxycodone, or phencyclidine which, in the judgment of the investigator, is indicative of non-prescribed drug use; and/or positive urine alcohol screen result in which, in the judgment of the investigator, is indicative of alcohol abuse or alcoholism
• •Consumption of prohibited medications within 1 week of informed consent, including buprenorphine
• •Consumption of grapefruit and grapefruit juice for at least one week before the study dose and until the end of the study