FAVIDOSE trial is a Phase I randomized, double blind controlled, monocentric, dose escalation clinical trial. The primary purpose of this trial is to evaluate tolerance of high doses of favipiravir for 14 days in healthy volunteers. This trial also looks to characterize favipiravir pharmacokinetics in blood and favipiravir levels in sperm. A pharmacogenetics analysis will be conducted in an attempt to identify genetic variants of metabolism and transport enzymes of favipiravir to explain the inter-individual variability of pharmacokinetic parameters of favipiravir.
Three sequential dose levels including distinctive participants:
* level 1: D1: 2400 mg BID; D2 to D13: 1600 mg BID and D14: 1600 mg in the morning; * level 2: D1: 2400 mg BID; D2 to D13: 2000 mg BID and D14: 2000 mg in the morning; * level 3: D1: 2400 mg BID; D2 to D13: 2400 mg BID andD14: 2400 mg in the morning.
Three study groups of maximum of 8 participants, 6 receiving favipiravir and 2 receiving placebo per dose level, three dose levels proposed. Seven additional participants with the same follow up will be included and randomized (6:1 ratio) at the maximum tolerated dose level to allow a satisfactory accurate characterization of pharmacokinetics and pharmacogenetics of favipiravir and their determinants (maximum 39 participants in total, taking into account 8 participants - 2 per dose level - replaced because loss of follow-up before the end of treatment).
Man between 50 and 75 years old without any desire to have children or woman between 18 and 75 years old ;
Subject considered healthy after a thorough general examination (questioning, physical examination);
For men: acceptance of semen collection by masturbation;
For men: acceptance of condom use from initiation of the investigational drug until 1 month after stopping the investigational drug;
Concomitant use or within 15 days prior to inclusion of another QT/QTc prolonging drug or drugs that may disrupt electrolyte levels, among others: loop diuretics, thiazide diuretics and related drugs (see list www.crediblemeds.org)
History of amiodarone use within 6 months prior to inclusion
History of gout or current treatment for gout or hyperuricemia
Treatment with pyrazinamide or any other drug known to induce hyperuricemia
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Treatment groupsSee each treatment group below.
Institut National de la Santé Et de la Recherche Médicale, France
Lead sponsor
FUJIFILM Toyama Chemical Co., Ltd.
Collaborator