Your browser doesn't support javascript.
loading
Development and Application of a Physiologically Based Pharmacokinetic Model for Elagolix in the Adult and Adolescent Population.
Zhang, Xinghai; Wang, Xuanxuan; Li, Rui; Zhang, Chenning; Du, Jianmin; Zhao, Hengli; Wen, Qing.
Afiliação
  • Zhang X; Department of Clinical Research Center, Central Hospital Affiliated to Shandong First Medical University, Jinan, 250013, China.
  • Wang X; Department of Clinical Research Center, Central Hospital Affiliated to Shandong First Medical University, Jinan, 250013, China.
  • Li R; Department of Clinical Research Center, Central Hospital Affiliated to Shandong First Medical University, Jinan, 250013, China.
  • Zhang C; Department of Clinical Research Center, Central Hospital Affiliated to Shandong First Medical University, Jinan, 250013, China.
  • Du J; Department of Clinical Research Center, Central Hospital Affiliated to Shandong First Medical University, Jinan, 250013, China.
  • Zhao H; Department of Clinical Research Center, Central Hospital Affiliated to Shandong First Medical University, Jinan, 250013, China. xiaolegold@163.com.
  • Wen Q; Department of Clinical Research Center, Central Hospital Affiliated to Shandong First Medical University, Jinan, 250013, China. jnlcsy_stu@163.com.
Clin Pharmacokinet ; 63(9): 1357-1370, 2024 Sep.
Article em En | MEDLINE | ID: mdl-39060899
ABSTRACT

INTRODUCTION:

Endometriosis, a common and distressing gynecological condition, affects fertility and causes pain, is often managed with medications such as Elagolix. The present study aimed to construct a physiologically based pharmacokinetic (PBPK) model for elagolix to predict its pharmacokinetics in different populations, including those with special conditions, to enhance treatment strategies for endometriosis.

METHODS:

The PBPK model was optimized using observational data based on the oral administration of elagolix in a healthy Chinese population under fasting conditions. Model accuracy was further verified by comparing the predicted postprandial elagolix concentration data for healthy Chinese individuals with observed data and by comparing these values with the predicted values in a US population model with renal injury or following multiple-dose administration.

RESULTS:

Elagolix pharmacokinetic (PK) profiles in the Chinese and American populations exhibited no differences that were attributable to ethnicity. The model predicted in vivo PK in adolescents aged 14-18 years, revealing no clinically significant differences in the effects of elagolix between adolescents and adults. In addition, no predicted PK differences in individuals with overweight were observed. However, notable variations emerged in those classified as obesity class 2 and above compared to healthy individuals.

CONCLUSION:

Our study presents a novel PBPK model for elagolix in healthy Chinese women, addressing a clinical data gap for its use in adolescents and obese patients. By validating the model with real-world factors, including diet and renal impairment, we provide initial pharmacokinetic predictions for these populations, contributing to a more informed clinical approach.
Assuntos
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pirimidinas / Modelos Biológicos Limite: Adolescent / Adult / Female / Humans / Middle aged Idioma: En Revista: Clin Pharmacokinet Ano de publicação: 2024 Tipo de documento: Article País de afiliação: China País de publicação: Suíça
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pirimidinas / Modelos Biológicos Limite: Adolescent / Adult / Female / Humans / Middle aged Idioma: En Revista: Clin Pharmacokinet Ano de publicação: 2024 Tipo de documento: Article País de afiliação: China País de publicação: Suíça