Actively Recruiting
Phase I Study to Assess Safety and Pharmacokinetics of High-Dose Favipiravir in Healthy Adults Aged 18 to 75
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2026-02-12
39
Participants Needed
1
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the tolerance and pharmacokinetics of high doses of favipiravir, a drug, in healthy adult volunteers aged 18 to 75 years. This Phase I randomized, double-blind, controlled trial aims to assess how well participants tolerate favipiravir over 14 days. The study also explores favipiravir levels in blood and sperm, and includes a genetic analysis to understand differences in how individuals process the drug. Participants will be assigned randomly to one of three dose levels of favipiravir or a matching placebo. Each dose level involves specific dosing schedules over 14 days, with doses ranging from 1600 mg to 2400 mg twice daily. A total of up to 39 participants will take part, including additional volunteers at the highest tolerated dose to better study drug levels and genetic factors. Throughout the study, participants will undergo monitoring of drug concentration in plasma at multiple time points, genetic testing, and sperm sampling. Researchers will assess tolerance over 6 months and collect safety data. The study involves regular clinical and laboratory assessments to ensure participant safety and to measure the drugs pharmacokinetic profile accurately.
CONDITIONS
Brief Title
Evaluation of Tolerance and Pharmacokinetic Profile of High Doses of Favipiravir in Healthy Volunteers
Research Team
C
Cedric LAOUNAN
P
Philippine ELOY
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