drugset / Trial / NCT01532518
Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
RandomizedParallel-groupOpen-labelTreatment
Summary
The present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance. In addition, the assessment of drug exposure (PK assessment) will provide additional information on the dose-effect relationship, thus supporting the dose selection and dosing schedule in the future studies.
Timeline
- Start
- 2011-08
- Primary completion
- 2012-07
- Completion
- 2012-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nepadutant | Protein / enzyme biologic | 0.1 mg/kg | Oral |
| Subject | Nepadutant | Protein / enzyme biologic | 0.5 mg/kg | Oral |
| Subject | Nepadutant | Protein / enzyme biologic | 1 mg/kg | Oral |
Indications
No indication recorded.