Phase I study on the pharmacokinetics of intravaginal, self-administered artesunate vaginal pessaries among women in Kenya.

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Tác giả: Cynthia Cheserem, George Githongo, Brenda Misiko, Chemtai Mungo, Cirilus Ogollah, Jackton Omoto, Mihaela Plesa, Lisa Rahangdale, Katherine Sorgi, William Zamboni

Ngôn ngữ: eng

Ký hiệu phân loại: 220.4047 Original texts, early versions, early translations

Thông tin xuất bản: United States : medRxiv : the preprint server for health sciences , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 699646

UNLABELLED: Cervical cancer remains a significant global health issue, especially in low- and middle-income countries (LMICs), where access to prevention and treatment is limited and women are at a higher risk of cervical cancer. Artesunate, a widely available drug used to treat malaria, has shown promise in treating human papillomavirus (HPV)-associated anogenital lesions including high-grade cervical precancer, in a recent Phase I studies in the United States. Data on the pharmacokinetics of artesunate following intravaginal use, and its implications on malaria resistance, are lacking. OBJECTIVES: The primary objective of this study is to investigate the pharmacokinetics of Artesunate (AS) and its active metabolite, dihydroartemisinin (DHA) following intravaginal use at the dosing and frequency intended for cervical precancer treatment. A secondary objective is to assess safety among study participants. METHODS: We are conducting a single-arm, phase I trial with a sample size of 12 female volunteers. Participants will self-administer artesunate vaginal pessaries in the study clinic daily for 5 consecutive days. Participants will have their blood drawn prior to receiving the first dose of artesunate on day one of the study and then will receive 8 blood draws on study day five, prior to artesunate administration and at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 8 hours after pessary administration. Pharmacokinetic parameters of artesunate and DHA will be calculated by way of quantitative analysis of with determination of maximum concentration (Cmax), time to Cmax (Tmax), area under the serum concentration versus time curve (AUC), apparent clearance, and elimination half-life (t1/2).
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