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Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects

Pharmacokinetics of Buprenorphine and Naloxone in Subjects With Mild to Severe Hepatic Impairment (Child-Pugh Classes, A, B, and C), in HCV-Seropositive Subjects, and in Healthy Volunteers

NCT01846455•Indivior Inc.

View on ClinicalTrials.gov

Summary

The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.

Detailed Description

This will be a multi-center, open-label study. After providing informed consent, subjects will undergo an outpatient screening period of up to 21 days. Screening procedures will include an assessment of mental status which will be repeated before dosing. Eligible subjects will then undergo hospital intake procedures and reside at the investigational site until Day 5. Subjects will be enrolled in 5-treatment groups as follows: (1) Group 1: Subjects with hepatic impairment classified as Child-Pugh A; (2) Group 2: Subjects with hepatic impairment classified as Child-Pugh B; (3) Group 3: Subjects with hepatic impairment classified as Child-Pugh C; (4) Group 4: Subjects with Hepatitis C Virus (HCV) infection but without hepatic impairment; and (5) Group 5: Subjects without hepatic disease or impairment. Group 5 is used as a control group

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Males or females between the ages of 18 and 65 years, inclusive
•Females should be surgically sterile, 2 years post-menopausal or have a negative plasma β-human chorionic gonadotropin (β-hCG) pregnancy test. Subjects of child-bearing potential must take reasonable precautions during the study to avoid pregnancy by agreeing to remain abstinent or to practice double-barrier forms of birth control from the time of informed consent through the last study visit. A negative plasma pregnancy (β-hCG) test at Screening and upon admission to the investigational site. Testing for β-hCG will need to be timed to ensure a negative pregnancy result at Day 1.
•Male subject agrees to use barrier contraception and spermicide when engaging in sexual activity with a female of child-bearing potential for at least 28 days after the study medication dose.
•Male subject agrees to refrain from sperm donations for the entire duration of the study and for at least 90 days after the study drug dose.
•Body mass index (BMI) of ≥ 18 to ≤ 33 kg\^m2.
•Subject agrees to the conditions of the study and signs the informed consent form

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
+8 more criteria

Locations (3)

Clinical Pharmacology of Miami, Inc.

Hialeah, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

American Research Corporation (ARC)

San Antonio, Texas, United States

Key Dates

Start Date

September 1, 2012

Primary Completion Date

April 1, 2013

Completion Date

May 1, 2013

Last Updated

October 24, 2016

Enrollment

ACTUAL participants

Conditions

Hepatic FailureHepatic ImpairmentChronic Hepatitis C Infection With Hepatic Coma

Interventions

2.0mg Buprenorphine/0.5mg Naloxone

DRUG

Promethazine

DRUG

A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

NCT07324616

Hepatic Impairment (HI)

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RECRUITINGPHASE1

Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants

NCT04271488

Hepatic Impairment

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RECRUITINGPHASE1

An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants

An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage

The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure

A Varegacestat Hepatic Impairment Study

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001