Tolerance and Pharmacokinetics Study of MNTX Tablets

Phase 1

Completed

• Conditions: Normal Healthy Volunteers
• Interventions: Drug: Oral methylnaltrexone; Drug: Oral placebo

• Registration Number: NCT01366339
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-06
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Oral methylnaltrexone	Oral methylnaltrexone
Arm 2	Oral methylnaltrexone	Oral methylnaltrexone
Arm 3	Oral methylnaltrexone	Oral methylnaltrexone
Arm 4	Oral placebo	Oral placebo

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States