Tolerance and Pharmacokinetics Study of MNTX Tablets

Normal Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366339
• Other study ID #: MNTX 1201
• Status: Completed
• Phase: Phase 1
• Start date: October 2003
• Est. completion date: December 2003

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Normal Healthy Volunteers

Intervention

Drug:
• Oral methylnaltrexone

• Oral placebo

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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