A Phase I Urodynamic Study of the Opioid Antagonist, Naloxone and Intravenous Methylnaltrexone Reverse Opioid Effects on Bladder Function in Healthy Volunteers

MNTX 206

This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.

2002-10-01

2003-05-01

2003-05-01

Completed

Early phase I

15

Inclusion Criteria: 1. Healthy males, 18 to 65 yrs with normal urinary function 2. Body weight less than 150 kg and Body Mass Index between 20-32. Exclusion Criteria: 1. Females 2. History of drug or alcohol abuse 3. History of significant chronic illness (cardiovascular, gastrointestinal, pulmonary, neurologic, endocrine, renal, hepatic, etc.) 4. Subjects who received opioids for one week or longer in the last 2 months.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}

2023-04-12