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

Primary Purpose

Liver Dysfunction

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SC Methylnaltrexone (MNTX)
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Dysfunction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Progenics Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Plasma Concentration of SC MNTX
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

Time of Maximum Plasma Concentration of SC MNTX
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
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
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
To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls.

Full Information

First Posted
May 27, 2011
Last Updated
November 26, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01367522
Brief Title
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function
Official Title
A Phase 1, Open-Label, Study to Evaluate Single Dose Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Volunteers With Impaired Hepatic Function
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SC Methylnaltrexone (MNTX)
Primary Outcome Measure Information:
Title
Plasma Concentration of SC MNTX
Description
To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls.
Time Frame
20 days
Secondary Outcome Measure Information:
Title
Time of Maximum Plasma Concentration of SC MNTX
Description
To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls.
Time Frame
20 days
Title
Area Under the Plasma Concentration versus Time Curve (AUC) of SC MNTX
Description
To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls.
Time Frame
20 days
Title
Percentage of SC MNTX Excreted in Urine
Description
To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls.
Time Frame
20 days
Title
Urinary Clearance of SC MNTX
Description
To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls.
Time Frame
20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females between the ages of 18-80 years Body weight greater than 100 lbs and BMI between 18-38 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: History of current alcohol abuse with less than 1 year abstinence Conditions possibly affecting drug absorption, e.g. gastrectomy or clinically significant diabetic gastroenteropathy. Currently pregnant or nursing Methadone use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tage Ramakrishna, MD
Organizational Affiliation
Progenics Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Progenics Pharmaceuticals, Inc.
City
Tarrytown
State/Province
New York
ZIP/Postal Code
10591
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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