NCT00655083

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

Pilot Study to Evaluate the Oral Absorption, Safety, and Tolerability of Nepadutant Administered as Single Oral Doses to Infants With Colic and Other Functional Gastrointestinal Disorders

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 6 Weeks – 24 Weeks
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Infantile Colic
• Infantile Functional Gastrointestinal Disorders

Interventions

Type	Name	Description
DRUG	Nepadutant	0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
DRUG	Nepadutant	0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-04-09
• Last updated: 2011-10-17
• Results posted: 2010-08-25

Locations

3 sites across 1 country: United States