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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menarini Group
• Treatments: MEN 11420

Criteria

Inclusion Criteria:

Subjects will be eligible for inclusion in the study if they meet all of the following criteria:

• Infants with a history consistent with a diagnosis of colic or other functional gastrointestinal disorders

• Age >6 weeks and < 24 weeks

• At least 44 weeks post-conceptual age at enrolment

• Normal growth

• Informed consent by parents (one or both) or legal guardian

• Caregiver available to be trained in collection and storage of used diapers

• Caregiver available to record feeding episodes and defecations on the diary

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

• Clinical evidence of major cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal (excluding infantile colic and other functional gastrointestinal disorders, unless associated to symptoms which are likely to interfere with drug absorption, e.g. frequent vomiting), haematological, severe dermatological or neurological pathology or other diseases;

• Previous major surgery or blood loss

• Intake of antimuscarinic drugs, simethicone, or dimethicone 24 hours before study treatment administration.