CClinicalTrials.gg
Sign In
CompletedNCT01367522Updated Nov 27, 2019

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

A Phase 1 interventional study of SC Methylnaltrexone (MNTX) in Liver Dysfunction, sponsored by Bausch Health Americas, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-27.

Sponsored by Bausch Health Americas, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Liver Dysfunction

Browse trials for

03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 24 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: SC Methylnaltrexone (MNTX)

Interventions

  • DrugSC Methylnaltrexone (MNTX)
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 20 days

Secondary outcomes

  1. 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.

    Time frame: 20 days

  2. 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.

    Time frame: 20 days

  3. 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.

    Time frame: 20 days

  4. 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.

    Time frame: 20 days

07

Study locations

1 site
  • Progenics Pharmaceuticals, Inc.
    Tarrytown, New York 10591, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01367522
Lead sponsor
Bausch Health Americas, Inc.
First posted
Jun 7, 2011
Start date
Mar 2004
Primary completion
Jul 2004
Completion
Jul 2004
Last update
Nov 27, 2019

Study contacts

Tage Ramakrishna, MD
study director · Progenics Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Liver Diseases→

Other studies from this sponsor

Bausch Health Americas, Inc.

Start the discussion