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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

SC Methylnaltrexone (MNTX)

Intervention Type DRUG

Interventions

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SC Methylnaltrexone (MNTX)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes