A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants

Status Completed

Clinical Trial Summary

The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine.

Clinical Trial Description

This trial aims to evaluate the oral adsorption of nepadutant (0.1 or 0.5 mg/Kg given as one single dose as oral solution) in infants divided in three age strata (from 6 to 24 weeks old). Oral absorption is evaluated by measuring the amount of nepadutant in the urine output collected during the 24 hours after oral administration with special diapers.

Safety and tolerability of the drug will be evaluated by monitoring any changes in signs/symptoms at medical examination and vital signs during the fist 4 hours post-dose in the Hospital site and then by the parents at home up to 24 hours and 1 week post nepadutant administration. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Colic
Digestive System Diseases
Gastrointestinal Diseases
Infantile Colic
Infantile Functional Gastrointestinal Disorders

Clinical Trial Details

NCT number	NCT00655083
Study type	Interventional
Source	Menarini Group
Contact
Status	Completed
Phase	Phase 1
Start date	March 2008
Completion date	May 2009

View Details

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