Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function

Phase 1

Completed

• Conditions: Liver Dysfunction
• Interventions: Drug: SC Methylnaltrexone (MNTX)

• Registration Number: NCT01367522
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	SC Methylnaltrexone (MNTX)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States