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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Cimetidine; Methylnaltrexone; Naltrexone

Criteria

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.