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

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Drug: methylnaltrexone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01366378

MNTX 1304

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Arm 1

Experimental group

Description:

methylnaltrexone (MNTX)

Treatment:

Drug: methylnaltrexone