Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

Phase 1

Completed

• Conditions: Healthy Adults
• Interventions: Drug: SC Placebo; Drug: IV Methylnaltrexone (MNTX); Drug: SC Methylnaltrexone (MNTX); Drug: Oral Paroxetine

• Registration Number: NCT01367535
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

Inclusion Criteria

1. Healthy males between the ages of 18 and 55
2. Non-Smokers
3. Body weight range form 154-220 lbs
4. No history of clinically significant metabolic disorders.

Exclusion Criteria

1. Any history of low CYP450 2D6 activity
2. History of alcohol abuse or recreational drugs
3. History of any clinically significant disease or condition affecting a major organ system
4. Donation or loss of blood, 60 days proceeding to screening visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4	SC Placebo	-
Arm 2	IV Methylnaltrexone (MNTX)	-
Arm 1	SC Methylnaltrexone (MNTX)	-
Arm 3	Oral Paroxetine	-

Primary Outcome Measures

Name	Time	Method
Plasma Concentration of MNTX	4 months	The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration of Paroxetine	4 months	The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.

Trial Locations

Locations (1)

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