Summary
Samenvatting vroege klinische ontwikkeling
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Dit is een samenvatting over het deel van de vroege klinische ontwikkeling
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Vroege klinische ontwikkeling(Dreesen)
Exploratieve/fase 0/microdosis/snuffel studies
Weinig niet-klinische data nodig starten tijdens discovery fase
1 of meerdere GM kandidaten
Kleine schaal single-cohort studies in mensen
Meestal in patiënten
1 site
Relatief goedkoop
Flexibel design
Subtherapeutische exposure enkel om vroege informatie te hebben over PK, target
attainment, MoA, biomerker en PD sneller met klinische trials beginnen
Geen MTD bepalen
Dosering
o Microdosis studies
Extrapolatie lineair naar therapeutische dosis onzekerheid over niet-lineaire
kinetiek IVIVE nodig voor correctie
Saturatie van metabole enzymes en/of transporters bij hoge dosis
Te weinig saturatie van target bij lage dosis target mediated drug
disposition (TMDD)
Basis PK en bevestiging metabolisatie
100 microgram approach: mag in meerdere keren + geen wash-out + single dose
toxiciteitstudie
500 microgram approach: max 100 per keer + wash-out + repeated dose
toxiciteitstudie nodig
o Subtherapeutische dosis range
Hogere dosis + geen washout
Single dose toxiciteit in rodent en non-rodent
o Therapeutische dosis range
Nog hoger + geen washout
Meer klinische vereisten
Analyse (voldoende gevoelig)
o 14C-gelabeld GM met AMS = plasma = invasief
o LC-MS/MS = plasma = invasief
o 11C of 18F-gelabeld GM net PET = niet-invasief (maar blootstelling aan straling)
Fase 1
o Veiligheid, verdraagbaarheid, PK en indien mogelijk PD
1. Risk assessment obv preklinische data (PK, selectiviteit, therapeutisch venster, …)
2. Plan voor klinisch ontwikkeling (advies van experten)
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