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The use of microtra...
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van Der Heijden, L. T.Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.;Antoni Van Leeuwenhoek The Netherlands Canc Inst, Div Pharmacol, Amsterdam, Netherlands.;Antoni Van Leeuwenhoek Canc Inst, Dept Pharm & Pharmacol, Div Pharmacol, Plesmanlaan 121, NL-1066 CX Amsterdam, Netherlands.
(författare)
The use of microtracers in food-effect trials : An alternative study design for toxic drugs with long half-lives exemplified by the case for alectinib
- Artikel/kapitelEngelska2023
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John Wiley & Sons,2023
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LIBRIS-ID:oai:DiVA.org:uu-523240
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-523240URI
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https://doi.org/10.1111/cts.13647DOI
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Språk:engelska
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Sammanfattning på:engelska
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The traditional design of food-effect studies has a high patient burden for toxic drugs with long half-lives (e.g., anticancer agents). Microtracers could be used to assess food-effect in patients without influencing their ongoing treatment. The feasibility of a microtracer food-effect study during steady-state of the therapeutic drug was investigated in an in silico simulation study with alectinib as an example for a relative toxic drug with a long half-life. Microtracer pharmacokinetics were simulated based on a previously published population pharmacokinetic model and used for estimation of a model with and a model without food as a covariate on oral bioavailability of alectinib (assuming a 40% food-effect). Power was defined as the fraction of clinical trials where a significant (p < 0.01) food-effect was identified. The proposed study design of 10 patients on steady-state treatment, 10 blood samples collected within 24 h after administration and an assumed food-effect of 40% had a power of 99.9%. The mean estimated food-effect was 39.8% (80% confidence interval: 31.0%-48.6%). The feasibility of microtracer food-effect studies was demonstrated. The design of the microtracer food-effect study allowed estimation of the food-effect with minimal influence on therapeutic treatment and reducing patient burden compared to the traditional study design for toxic drugs with long half-lives.
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Steeghs, N.Netherlands Canc Inst, Antoni Van Leeuwenhoek Hosp, Dept Clin Pharmacol, Div Med Oncol, Amsterdam, Netherlands.
(författare)
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Beijnen, J. H.Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.;Antoni Van Leeuwenhoek The Netherlands Canc Inst, Div Pharmacol, Amsterdam, Netherlands.;Univ Utrecht, Fac Sci, Dept Pharmaceut Sci, Div Pharmaco epidemiol & Clin Pharmacol, Utrecht, Netherlands.
(författare)
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Huitema, A. D. R.Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.;Antoni Van Leeuwenhoek The Netherlands Canc Inst, Div Pharmacol, Amsterdam, Netherlands.;Univ Med Ctr Utrecht, Dept Clin Pharm, Utrecht, Netherlands.;Princess Maxima Ctr, Dept Pharmacol, Utrecht, Netherlands.
(författare)
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Dorlo, Thomas P. C.,1983-Uppsala universitet,Institutionen för farmaci,Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands; Antoni Van Leeuwenhoek The Netherlands Canc Inst, Div Pharmacol, Amsterdam, Netherlands(Swepub:uu)thodo249
(författare)
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Antoni Van Leeuwenhoek The Netherlands Canc Inst, Dept Pharm & Pharmacol, Amsterdam, Netherlands.;Antoni Van Leeuwenhoek The Netherlands Canc Inst, Div Pharmacol, Amsterdam, Netherlands.;Antoni Van Leeuwenhoek Canc Inst, Dept Pharm & Pharmacol, Div Pharmacol, Plesmanlaan 121, NL-1066 CX Amsterdam, Netherlands.Netherlands Canc Inst, Antoni Van Leeuwenhoek Hosp, Dept Clin Pharmacol, Div Med Oncol, Amsterdam, Netherlands.
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:Clinical and Translational Science: John Wiley & Sons16:12, s. 2557-25641752-80541752-8062
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