Actively Recruiting
Evaluation of Tolerance and Pharmacokinetic Profile of High Doses of Favipiravir in Healthy Volunteers
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2026-02-12
39
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
Sponsors
I
Institut National de la Santé Et de la Recherche Médicale, France
Lead Sponsor
F
FUJIFILM Toyama Chemical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluation of Tolerance and Pharmacokinetic Profile of High Doses of Favipiravir in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 50 to 75 years without desire to have children or women aged 18 to 75 years
- Healthy based on general examination including medical history and physical exam
- Men must accept semen collection by masturbation
- Men must agree to use condoms from starting the drug until one month after stopping
- Women of childbearing potential must use two effective contraceptive methods including a male condom from inclusion until one month after stopping
- Blood tests showing normal potassium, calcium, prothrombin rate, and activated partial thromboplastin time
- ALT, ASAT, and uric acid levels below the upper limit of normal
- Other blood tests without clinically significant abnormalities
- Urine dipstick test without significant abnormalities
- Negative urine drug screen for specified substances
- Ability to take the drug orally and follow dosing instructions
- Signed informed consent
- Enrollment in or beneficiary of a social security plan
- Willingness to follow lifestyle guidelines during the study
You will not qualify if you...
- Use of QT/QTc prolonging drugs or drugs affecting electrolytes within 15 days before inclusion
- Amiodarone use within 6 months prior
- History or current treatment for gout or hyperuricemia
- Treatment with pyrazinamide or other drugs causing high uric acid
- Hypersensitivity to nucleoside analogs targeting viral RNA polymerase
- Allergy to favipiravir or placebo components
- Pregnant or breastfeeding women
- Men with vasectomy or known infertility
- Refusal to complete all study visits and tests
- Abnormal ECG findings including prolonged PR, QRS, QTc intervals or abnormal repolarization
- Low blood pressure (systolic below 100 mmHg)
- History or active serious medical conditions that could affect safety or study data
- Family or personal history of long QT syndrome, torsades de pointes, or sudden death
- Severe liver impairment
- Certain gastrointestinal diseases like ileus or colitis
- Participation in other investigational studies
- Legal protection status such as guardianship
- Administrative detention
- Likely inability to comply with the study or communication barriers
- Unreachable in emergencies
- First-degree relative from East or Southeast Asia
- Positive COVID-19 antigen test on Day 1
- Abnormal potassium levels before treatment start
- Positive pregnancy test on Day 1
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Bichat - Claude Bernard
Paris, France, 75018
Actively Recruiting
Research Team
C
Cedric LAOUNAN
CONTACT
P
Philippine ELOY
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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