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A Phase 1 Double-blind, Randomised, Placebo-controlled, Dose Escalating Study to Assess the Safety and Tolerability of Single and Multiple Oral Doses of CHR-5154 and the Effect of the Fasted and Fed State on Pharmacokinetics of CHR-5154 and CHR-5426 in Healthy Male Volunteers

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DataCite Commons2025-04-01 更新2026-05-07 收录
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https://search.vivli.org/doiLanding/studies/00001513/isLanding
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Primary Objective: • To determine the safety and tolerability of single and multiple ascending oral doses of CHR-5154 in healthy volunteers. Secondary Objectives: - To determine the pharmacokinetic profile of CHR-5154 and its metabolite CHR-5426. - To compare the pharmacokinetic profile of CHR-5154 and CHR-5426 after a single dose of CHR-5154 in the fed and fasted state.

主要研究目标:• 明确CHR-5154单次及多次递增口服给药在健康受试者中的安全性与耐受性。次要研究目标: - 明确CHR-5154及其代谢物CHR-5426的药代动力学特征; - 对比CHR-5154单次给药后,进食与空腹状态下CHR-5154与CHR-5426的药代动力学特征。
提供机构:
Vivli
创建时间:
2018-10-27
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