NCT01367522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

May 27, 2011

Last Update Submit

November 26, 2019

Conditions

Liver Dysfunction

Outcome Measures

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.

    20 days

Secondary Outcomes (4)

  • Time of Maximum Plasma Concentration of SC MNTX

    20 days

  • Area Under the Plasma Concentration versus Time Curve (AUC) of SC MNTX

    20 days

  • Percentage of SC MNTX Excreted in Urine

    20 days

  • Urinary Clearance of SC MNTX

    20 days

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: SC Methylnaltrexone (MNTX)

Interventions

SC Methylnaltrexone (MNTX)DRUG
Arm 1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Tage Ramakrishna, MD

    Progenics Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 7, 2011

Study Start

March 1, 2004

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)