Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX

Bausch Health Americas, Inc.18 enrolled

Overview

This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Adult Subjects

Interventions

methylnaltrexoneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy males and females between the ages of 18 and 45 2. Subjects who are non-smokers 3. Subjects with body weights with range of 154-220 lbs. Exclusion Criteria: 1. Females who are pregnant or lactating 2. Subjects with a history of any clinically significant disease or condition affecting a major organ system 3. Subjects with ECG abnormalities 4. Subjects who have tested positive for hepatitis B, hepatitis C or HIV 5. Subjects who have had a diagnosis of alcohol or substance dependence with the past 12 months 6. Subjects with positive urine results for drugs of abuse.

Locations (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States