Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis

Insa Winzenborg, Ahmed Nader, Akshanth R. Polepally, Mohan Liu, Jacob F. Degner, Jacob Degner, Cheri E Klein, Nael M Mostafa, Peter Noertersheuser, Juki Ng
Clinical pharmacokinetics · 2018 · vol. 57(10) , pp. 1295–1306 · doi:10.1007/s40262-018-0629-6 · PMID:29476499 · W2788703728
article OA: closed CC0 ⤵ 19 in-corpus citations
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⚙ AI-generated summary by claude@2026-06+body, 2026-06-07 ⓘ

Elagolix population pharmacokinetics were characterized using a two-compartment model, with OATP1B1 genotype showing a statistically insignificant effect on clearance.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-07 ⓘ

This study developed a population pharmacokinetic model for elagolix using pooled data from nine clinical studies totaling 1624 premenopausal women, including healthy volunteers (phase I) and women with endometriosis (phase III). Using nonlinear mixed-effects modeling, the authors found elagolix pharmacokinetics were best described by a two-compartment model with a lag time in absorption, and they tested 15 covariates for effects on apparent clearance and/or distribution volumes. Only OATP1B1 genotype status showed a statistically significant effect on elagolix CL/F, which the authors judged as not clinically meaningful, and pharmacokinetic parameters were similar between healthy women and women with endometriosis. This paper is centrally about endometriosis — it characterizes elagolix population pharmacokinetics in women with endometriosis compared with healthy women.

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Condition tags

mesh:D004715endometriosis

MeSH descriptors

Endometriosis Hydrocarbons, Fluorinated Models, Biological Premenopause Pyrimidines Adult Clinical Trials, Phase I as Topic Clinical Trials, Phase III as Topic Endometriosis Endometriosis Female Genotype Humans Hydrocarbons, Fluorinated Inactivation, Metabolic Liver-Specific Organic Anion Transporter 1 Liver-Specific Organic Anion Transporter 1 Premenopause Pyrimidines Receptors, LHRH

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