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

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Liver Dysfunction

Treatments: Drug: SC Methylnaltrexone (MNTX)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367522

MNTX 1107

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: SC Methylnaltrexone (MNTX)