Liver Dysfunction
Conditions
Brief summary
This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will receive a subcutaneous dose of MNTX. Eight subjects with normal hepatic function and eight subjects from each classification of hepatic impairment will be enrolled. Plasma samples will be collected before and at specified intervals after dosing and the concentration of MNTX will be analyzed.
Interventions
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females between the ages of 18-80 years 2. Body weight greater than 100 lbs and BMI between 18-38 3. Liver values that are abnormal must not be clinically relevant as judged by the investigator. Liver enzyme and bilirubin must be less than 5 times the upper normal of reference range and may be repeated under fed conditions if abnormal. Stable hepatitis patients as well as cirrhosis patients of either etiology.
Exclusion criteria
1. History of current alcohol abuse with less than 1 year abstinence 2. Conditions possibly affecting drug absorption, e.g. gastrectomy or clinically significant diabetic gastroenteropathy. 3. Currently pregnant or nursing 4. Methadone use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of SC MNTX | 20 days | To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of Maximum Plasma Concentration of SC MNTX | 20 days | To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls. |
| Area Under the Plasma Concentration versus Time Curve (AUC) of SC MNTX | 20 days | To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls. |
| Percentage of SC MNTX Excreted in Urine | 20 days | To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls. |
| Urinary Clearance of SC MNTX | 20 days | To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls. |
Countries
United States
Outcome results
None listed