ArticlePharmaceutical research2004
Population pharmacokinetic modeling of a subcutaneous depot for GnRH antagonist degarelix.
Article in Pharmaceutical research, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed.
- Effect of Degarelix, a Gonadotropin-Releasing Hormone Receptor Antagonist for the Treatment of Prostate Cancer, on Cardiac Repolarisation in a Randomised, Placebo and Active Comparator Controlled Thorough QT/QTc Trial in Healthy Men.Clinical drug investigation · 2017Trial
- Population pharmacokinetic/pharmacodynamic (PK/PD) modelling of the hypothalamic-pituitary-gonadal axis following treatment with GnRH analogues.British journal of clinical pharmacology · 2007Trial
- Stochastic differential equations in NONMEM: implementation, application, and comparison with ordinary differential equations.Pharmaceutical research · 2005Trial
- Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.The AAPS journal · 2020Article
- Update on male hormonal contraception.Therapeutic advances in endocrinology and metabolism · 2019Review
- Degarelix versus luteinizing hormone-releasing hormone agonists for the treatment of prostate cancer.Expert opinion on pharmacotherapy · 2017Review
- Degarelix.Drugs · 2009Article
- Population pharmacokinetics and pharmacodynamics for treatment optimization in clinical oncology.Clinical pharmacokinetics · 2008Review
- Pharmacokinetic/pharmacodynamic modelling of GnRH antagonist degarelix: a comparison of the non-linear mixed-effects programs NONMEM and NLME.Journal of pharmacokinetics and pharmacodynamics · 2004Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe objective of this study is to develop a population pharmacokinetic (PK) model that describes the subcutaneous (SC) depot formation of gonadotropin-releasing hormone (GnRH) antagonist degarelix, which is being developed for treatment of prostate cancer, exhibiting dose-volume and dose-concentration dependent absorption.
methodsThe PK analysis is made in NONMEM through joint analysis of data from two phase I clinical studies; an intravenous infusion study and a single SC dose escalation study. The SC absorption is modeled using an approximation to Ficks' second law of diffusion out of a spherical depot. The dose-volume effect on the SC release is estimated using a B-spline basis whereas the bioavailability is modeled as a function of the dose-concentration.
resultsThe SC depot model is approximated by using two concentric spherical compartments for the SC absorption combined with a two-compartment disposition model. The results indicate that the volume effect is most apparent at low injection volumes whereas the effect is diminishing at higher injection volumes. The dose-concentration effect on the bioavailability is estimated to decrease at increasing dose-concentrations.
conclusionsThe presented SC depot model describes the PK profile of GnRH antagonist degarelix. This modeling approach might also be applicable for other depot-formulated drugs exhibiting complex PK profiles.
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15139513What OpenQuestion holds
Registered trials
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