drugset / Trial / NCT01055704

Effect of Methylnaltrexone on GI Transit in Healthy Volunteers

NCT01055704

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a single-center, randomized, double blind, placebo-controlled study evaluating the effects of placebo, codeine, methylnaltrexone and codeine with methylnaltrexone on gastrointestinal motility and colonic transit of solids in healthy human subjects. The hypotheses are: 1. Methylnaltrexone administered subcutaneously enhances gastrointestinal motility with acceleration of overall colonic transit, and ascending colon emptying of solids in healthy humans. 2. Methylnaltrexone significantly accelerates colonic transit that is delayed by codeine

Timeline

Start
2009-11
Primary completion
2010-02
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Codeine Small molecule 30 mg Oral
Subject Methylnaltrexone Other / unclassified 0.3 mg/kg Subcutaneous