Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Healthy Volunteers

Treatments: Drug: IV Methylnaltrexone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367587

MNTX 253

Details and patient eligibility

About

This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Must be male or non-pregnant female volunteers
2. Must be 18 to 65 yrs of age
3. Must have no significant active disease states

Exclusion criteria

1. History or current evidence of disease (cardiovascular, respiratory, endocrine, renal, hepatic, hematological, or psychiatric)
2. Illicit drug users
3. Subjects who received an experimental new drug in the past 30 days
4. Subjects with any laboratory findings outside normal limits

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: IV Methylnaltrexone