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

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01367522
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Dysfunction	Drug: SC Methylnaltrexone (MNTX)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2004
• Actual Primary Completion Date: Jul 1, 2004
• Actual Study Completion Date: Jul 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: SC Methylnaltrexone (MNTX)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Progenics Pharmaceuticals, Inc.	Tarrytown	New York	United States	10591

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01367522
• Other Study ID Numbers: MNTX 1107
• First Posted: Jun 7, 2011
• Last Update Posted: Nov 27, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Liver Diseases; Methylnaltrexone

Study Results

No Results Posted as of Nov 27, 2019