Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

Healthy Adults Clinical Trial

Official title:

A Phase I, Randomized, Open-Label, Active- and Placebo-Controlled Parallel Group Study of the Effect of Subcutaneous and Intravenous Methylnaltrexone on CYP450 2D6 Activity in Healthy Extensive Metabolizers of Dextromethorphan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367535
• Other study ID #: MNTX 1108
• Status: Completed
• Phase: Phase 1
• Start date: March 2006
• Est. completion date: August 2006

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• SC Methylnaltrexone (MNTX)

• IV Methylnaltrexone (MNTX)

• Oral Paroxetine

• SC Placebo

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals	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	Plasma Concentration of MNTX	The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.	4 months
Secondary	Plasma Concentration of Paroxetine	The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.	4 months