Phase 1
Completed N=20
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
Infantile Colic · Infantile Functional Gastrointestinal Disorders
Source: ClinicalTrials.gov NCT00655083 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups. — 5041; 6474; 2095; 3727 ng
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups. |
1127 | — |
| PRIMARY Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups. |
1127 | — |
| SECONDARY Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants. |
3 | — |
| SECONDARY Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants. |
3 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00655083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.