Tolerance and Pharmacokinetics Study of MNTX Tablets

A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers

This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.

Study Overview

• Status: Completed
• Conditions: Normal Healthy Volunteers
• Intervention / Treatment: Drug: Oral methylnaltrexone; Drug: Oral placebo

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Weight between 55 and 85 kg
2. In good health with no evidence of a clinically significant chronic medical condition
3. Non-Smokers.

Exclusion Criteria:

1. History of asthma, allergic skin rash, significant allergy or other immunologic disorder
2. Known or suspected hypersensitivity to opioids or opioid antagonists
3. History or suspicion of alcohol or drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Oral methylnaltrexone	Drug: Oral methylnaltrexone
Experimental: Arm 2; Oral methylnaltrexone	Drug: Oral methylnaltrexone
Experimental: Arm 3; Oral methylnaltrexone	Drug: Oral methylnaltrexone
Placebo Comparator: Arm 4; Oral placebo	Drug: Oral placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax) of oral doses of MNTX	To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX	To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers	7 days
Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX	To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers	7 days
Half-life of oral doses of MNTX	To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers	7 days

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): December 1, 2003
• Study Completion (Actual): December 1, 2003

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 6, 2011

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Methylnaltrexone
• Other Study ID Numbers: MNTX 1201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No