Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Drug: SC Methylnaltrexone (MNTX); Drug: IV Methylnaltrexone (MNTX); Drug: Oral Paroxetine; Drug: SC Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367535

MNTX 1108

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: SC Methylnaltrexone (MNTX)

Arm 2

Experimental group

Treatment:

Drug: IV Methylnaltrexone (MNTX)

Arm 3

Active Comparator group

Treatment:

Drug: Oral Paroxetine

Arm 4

Placebo Comparator group

Treatment:

Drug: SC Placebo