Healthy Adults
Conditions
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.
Interventions
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed