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
21 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
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 drug's pharmacokinetic profile accurately.
CONDITIONS
Brief 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
- Considered healthy after a thorough general examination
- Men must accept semen collection by masturbation
- Men must agree to use condoms from drug start until one month after stopping
- Women of childbearing potential must use two effective contraceptive methods from inclusion until one month after stopping
- Blood chemistry values within normal limits for specified tests
- Urine dipstick without significant abnormalities
- Negative urine toxicology screen
- Ability to take the investigational drug orally and follow dosage
- Signed informed consent
- Member or beneficiary of a social security plan
- Adherence to lifestyle considerations during participation
You will not qualify if you...
- Use of QT/QTc prolonging drugs or drugs affecting electrolytes within 15 days prior
- Amiodarone use within 6 months prior
- History or treatment of gout or hyperuricemia
- Treatment with pyrazinamide or other drugs causing hyperuricemia
- Hypersensitivity to nucleoside analogs or study drug components
- Pregnant or breastfeeding women
- Men with history of vasectomy or known infertility
- Refusal to complete study visits and examinations
- ECG abnormalities including PR >200ms, QRS >100ms, QTc >450ms
- Systolic blood pressure <100 mmHg
- History or active significant diseases affecting multiple organs or systems
- Personal or family history of long QT syndrome, torsades de pointes, or sudden death
- Severe hepatic impairment
- Gastrointestinal pathology like ileus or colitis
- Current participation in another investigational study
- Legal protection measures or administrative detention
- Inability to communicate or be contacted in emergencies
- First-degree relative from East or Southeast Asia
- Positive SARS-CoV-2 antigen test at treatment start
- Abnormal blood potassium within 8 days before treatment
- Positive pregnancy test at treatment start
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive high doses of favipiravir or placebo tablets according to assigned dosage levels.
Multiple visits for drug administration and pharmacokinetic assessments on Days 1, 3, 7, 10, 14, and 15
Duration - Up to 6 months
Participants are monitored for tolerance and safety after completing treatment.
Visits for tolerance assessments up to 6 months post-treatment
Trial Site Locations
Total: 1 location
1
University Hospital Bichat - Claude Bernard
Paris, France, 75018
Actively Recruiting
Research Team
C
Cedric LAOUNAN
P
Philippine ELOY
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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