A prospective phase 1, single-dose, open-label, multi-centre clinical trial to evaluate the pharmacokinetics and safety of M0003 in young children aged between 1 and 36 months.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

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

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The characterization of the pharmacokinetic profile of a single oral dose of M0003 in young children.<br>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

Secondary Outcome Measures

Name	Time	Method

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