Intended indication for product under development: Infant gastro-oesophageal reflux disease (GORD) MedDRA version: 9.1 Level: LLT Classification code 10017885 Term: Gastrooesophageal reflux disease
Conditions
Interventions
Product Name: M0003
Product Code: M0003
Pharmaceutical Form: Oral solution
Current Sponsor code: M0003
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number:
Sponsors
Movetis NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Boy or girl, aged 30 days up to 36 months at Visit 1 (gestational age at least 40 weeks). 2. Child hospitalized or in day care and requiring an iv catheter 3. Functional GI system (e.g. no ileus, no diarrhea) 4. Parents or legal representative voluntarily signed written Informed Consent Form (ICF) in accordance with the regional laws or regulations, before the first trial related activity. 5. Parents or legal representative are willing to adhere to all trial requirements. If the results of the biochemistry, haematology, or urinalysis tests are not within the laboratory's reference ranges, the subject can be included only on condition that the investigator judges that the deviations are not clinically significant. This should be clearly recorded in the Case Report Form (CRF). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Congenital abnormalities of the GI tract, heart, or liver. 2. Sepsis 3. Serious concurrent systemic disorders, including chronic renal disease or chronic liver disease. 4. Subject with clinically significant abnormal laboratory results at Visit 1. 5. Significant haematemesis or apparent life-threatening events (ALTEs). 6. Treatment with a histamine-2-receptor antagonist (H2RA), antacid, sucralfate, prostaglandin, or motility agent within 3 days prior to Visit 2. 7. Treatment with a proton pump inhibitor or potent CYP3A4 inhibitor within 7 days before Visit 2. 8. QTcB > or = 460 ms (at Visit 1 or 2), congenital prolonged QT syndrome, prolonged QTc secondary to diabetes mellitus, or family history of prolonged QT syndrome. 9. Significant arrhythmias, including ventricular arrhythmias, 2nd or 3rd degree atrioventricular block, congestive heart failure or ischaemic heart disease, ventricular tachycardia, and torsade de pointes. 10. History of significant arrhythmias in other siblings from the same parents or in the parents. 11. History of sudden infant death in other sibling from the same parents and/or history of a serious ALTE in the subject or other sibling from the same parents. 12. Any condition that, in the opinion of the Investigator(s) would complicate or compromise the trial (e.g., human immunodeficiency virus [HIV] infection, gastroduodenal ulcer, …) or the well-being of the subject, or evidence of any clinically relevant pathology that could interfere with the trial results or put the subject’s safety at risk. 13. Any condition in the parent/guardian/caregiver or legal representative associated with poor subject compliance (e.g., substance abuse) or inability of the parent/guardian/caregiver or legal representative to return with the child for scheduled visits. 14. Participation in any other investigational new drug trial and/or cohort trial. 15. Subject is a first or second line relative of the Investigator(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The characterization of the pharmacokinetic profile of a single oral dose of M0003 in young children. The assessment of short-term safety and tolerability of a single oral dose of M0003 in young children. ;Secondary Objective: ;Primary end point(s): To assess the pharmacokinetic profile, safety and tolerability of a single oral dose of M0003 in young children | — |
Countries
Belgium, Netherlands
Outcome results
None listed