Microdosing in children: elucidating age-related changes in oral absorptio
Phase 1
- Conditions
- Age-related changes in intestinal drug metabolism in childrenTherapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2011-005497-28-NL
- Lead Sponsor
- Erasmus MC - Sophia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Age 0 until 6 years
At least 32 weeks of post conceptual age
Possess an intravenous or intra-arterial access for blood sampling
Need for paracetamol intravenously
Parental informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
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
Anticipated death in 48 hours
Withdrawal of informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To elucidate the developmental pattern of important intestinal drug metabolizing pathways using microdosing in neonates and infants;<br> Secondary Objective: To show the feasibility of microdosing in children for use in mechanistic pharmacology studies and ‘first-in-child’ drug trials<br> To determine the effect of genetic polymorphisms on intestinal metabolism of paracetamol in children<br> ;Primary end point(s): Pharmacokinetics of the labeled and unlabeled parent compound and metabolites will be determined. Results will be stratified by age and population pharmacokinetics will be used. This will enable us to determine the ontogeny of the intestinal paracetamol metabolism pathways.;Timepoint(s) of evaluation of this end point: Time after completion of the last included patient
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): To show the feasibility of microdosing in children for use in mechanistic pharmacology studies and ‘first-in-child’ drug trials.<br> To study the effect of co-variates on drug disposition.<br> Co-variates: gender, co-medication, laboratory markers (if determined as part of clinical care): inflammation marker (CRP, leucocyte count, IL6, TNF-alpha, PCT, NGAL), DNA (for genes related to paracetamol disposition, e.g. UGT1A6)<br> ;Timepoint(s) of evaluation of this end point: Time after completion of the last included patient