Pediatric microdosing: elucidating age-related changes in oral absorption

Pediatric microdosing: elucidating age-related changes in oral absorption - PedMic

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39097

Enrollment

Registered

2013-04-16

Start date

2014-01-31

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ontogenie van medicamenteuze intestinale absorptie en metabolisme age related changes in drug metabolism and absorption

Interventions

One time administration of labeled microdose paracetamol, 3 microgram/kg 14-C paracetamol

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Age 0 to 6 years inclusive At least 32 weeks of post conceptual age Intravenous or intra-arterial access for blood sampling in place Receiving paracetamol IV Parental informed consent

Exclusion criteria

Exclusion criteria: Anticipated death in 48 hours No informed consent ECMO treatment Circulatory failure: - receiving more than 1 vasopressor or - increase of vasopressor drug dose in the last 6 hours Renal disorders - In need of renal dialysis - Estimated risk for kidney injury or failure at least 'risk for renal dysfunction' according to pRIFLE criteria. Which means an estimated creatinine clearance decreased by 25% or more, or urine output of 2SD in age appropriate liver enzymes measurement (ASAT and ALAT) Gastrointestinal disorders - Ileus, diarrhea, short bowel disease, underlying inflammatory bowel disease, pancreatic insufficency, (e.g. cystic fibrosis), celiac disease Use of co-medication known to affect paracetamol metabolism (according to the Farmacotherapeutische Kompas, www.fk.cvz.nl)

Design outcomes

Primary

Measure	Time frame
1. Plasma paracetamol to APAP-glucuronide clearance, as surrogate marker of UGT activity in vivo	—

Secondary

Measure	Time frame
Secundary outcomes are: 1. The following parameters will be estimated for both formulations: paracetamol and metabolite plasma and urinary clearance, volume of distribution, AUC, Cmax, Tmax, plasma and urinary APAP-glu/APAP-sulfate ratio. Oral bioavailability of paracetamol. In feces: paracetamol and metabolite appearance. Metabolites to be studied: Paracetamol-glucuronide (APAP-glu), paracetamol-4-hydroxysulfate (4-O-Sul), paracetamol-3-hydroxysulfate (3-O-Sul), paracetamol-3-cysteine (Cys), paracetamol-3-N-acetylcysteïne (Mer). 2. Description of the feasibility of a microdosing study in a pediatric population.	—

Measure

Time frame

Secundary outcomes are: 1. The following parameters will be estimated for both formulations: paracetamol and metabolite plasma and urinary clearance, volume of distribution, AUC, Cmax, Tmax, plasma and urinary APAP-glu/APAP-sulfate ratio. Oral bioavailability of paracetamol. In feces: paracetamol and metabolite appearance. Metabolites to be studied: Paracetamol-glucuronide (APAP-glu), paracetamol-4-hydroxysulfate (4-O-Sul), paracetamol-3-hydroxysulfate (3-O-Sul), paracetamol-3-cysteine (Cys), paracetamol-3-N-acetylcysteïne (Mer). 2. Description of the feasibility of a microdosing study in a pediatric population.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)