Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

Bausch Health Americas, Inc.54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Adults

Interventions

SC Methylnaltrexone (MNTX)DRUG

IV Methylnaltrexone (MNTX)DRUG

Oral ParoxetineDRUG

SC PlaceboDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Progenics Pharmaceuticals

Tarrytown, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 4 months

Secondary Outcomes

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.

Time frame: 4 months

Data from ClinicalTrials.gov

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