Infectious DiseasePhase 1FAVIDOSENCT06024421
Evaluation of Tolerance and Pharmacokinetic Profile of High Doses of Favipiravir in Healthy Volunteers
A Phase 1 study testing favipiravir in people with Infectious Disease and Pharmacology, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease, Pharmacology
- What is being tested?
- favipiravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2024to Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
- For women of childbearing potential: effective contraceptive method combining two methods of contraception (one female contraceptive method combined with male condom use) from the inclusion visit until 1 month after discontinuation of the investigational drug;
- Blood chemistry:
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- Kalemia, Calcemia, Prothrombin rate (PT), Activated partial thromboplastin time (APTT): values within laboratory normal;
- ALT, ASAT, Uricemia: values below the upper limit of the laboratory normal;
- Other biological results (Blood count; Natremia; Phosphoremia; Chloremia; Fasting blood glucose; Gamma glutamyl transpeptidase; Urea; Total bilirubin; Creatinine; CPK; Lactate dehydrogenase; Albuminemia; Proteinemia; Triglycerides; C-reactive protein; Albumin/Globulin ratio; Alkaline phosphatase) with no clinically significant abnormality.
- NB: A parameter outside the usual values considered clinically significant may, at the investigator's discretion, be tested a second time on another sample taken outside of a visit planned in the protocol before the initiation of the experimental drug.
- Urine dipstick (biochemistry: leukocyturia, proteinuria and hematuria) without clinically significant abnormality;
- Urine tox screen negative (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates);
- Ability to take the investigational drug orally and adherence to the dosage of the investigational drug;
- Acceptance and signing of the informed consent;
- Membership in a social security plan or beneficiary of such a plan;
- Adherence to lifestyle considerations (see section 5.5) during participation in this research.
Who cannot join
- 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
- History of hypersensitivity reaction to a nucleoside analog targeting viral RNA polymerase
- Known hypersensitivity to any of the components (favipiravir or placebo)
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- Pregnant or breastfeeding women
- For men: history of vasectomy or known history of infertility.
- Refusal of the subject to complete all the visits, clinical and paraclinical examinations planned by the study
- On ECG: PR >200ms, QRS >100ms QTc >450ms and morphological appearance of abnormal repolarization
- PAS <100 mmHg
- Any history or active cardiovascular, pulmonary, intestinal, hepatic, renal, metabolic, hematologic, neurologic, bone, joint, muscular, psychiatric, systemic, ocular, gynecologic, andrologic, or infectious disease (including active HIV, HCV, or HBV infection), or any acute condition, which in the judgment of the investigator could be detrimental to the volunteer and/or interfere with or limit the protocol evaluation and data analysis
- Personal or family history of long QT syndrome, torsades de pointes or sudden death
- Patient with severe hepatic impairment
- Gastrointestinal pathology such as ileus, colitis or enterocolitis
- Treatment with another investigational drug or other investigational procedure (clinical trial, clinical investigation of a medical device, category 1 or 2 research involving humans);
- A person who is subject to a legal protection measure (safeguard of justice, curatorship, guardianship);
- Person placed in administrative detention;
- Person who, in the judgment of the investigating physician, may be non-observant during the study, or unable to communicate due to a language barrier or mental disorder
- Person who cannot be contacted in an emergency
- Person with at least one first-degree relative from East Asia or Southeast Asia.
- Secondary Exclusion Criteria
- Participants with at least one of the following criteria will not start the experimental treatment at D1 if they are already randomized:
- Positive nasopharyngeal antigen test for SARS-CoV-2 at D1 (prior to treatment initiation)
- Blood potassium levels outside the normal laboratory range within 8 days prior to treatment initiation (D1)
- ECG: PR >200ms, QRS >100ms QTc >450ms and morphological appearance of abnormal repolarization on Day 1
- Positive pregnancy test on Day 1 (before initiation of treatment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital Bichat - Claude Bernard
Paris, 75018
Xavier Duval
Xavier Duval
About this study
Official title: EVALUATION DE LA TOLERANCE ET DU PROFIL PHARMACOCINETIQUE DE DOSES ELEVEES DE FAVIPIRAVIR CHEZ LE VOLONTAIRE SAIN
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:
Read more
- 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
- Infectious Disease, Pharmacology
- Being tested
- favipiravir, Placebo
- Keywords
- healthy volunteer, dose escalation, tolerance, pharmacokinetics, favipiravir
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
favipiravirDrug
Light yellow, film-coated tablet, each containing 200 mg of favipiravir
PlaceboDrug
Light yellow, film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| level 1: experimental | Experimental | D1: 2400 mg BID; D2 to D13: 1600 mg BID and D14: 1600 mg in the morning Receives: Drug: favipiravir |
| level 2: experimental | Experimental | D1: 2400 mg BID; D2 to D13: 2000 mg BID and D14: 2000 mg in the morning Receives: Drug: favipiravir |
| level 3: experimental | Experimental | D1: 2400 mg BID; D2 to D13: 2400 mg BID andD14: 2400 mg in the morning Receives: Drug: favipiravir |
| level 1: placebo | Placebo comparator | D1: 2400 mg BID; D2 to D13: 1600 mg BID and D14: 1600 mg in the morning Receives: Drug: Placebo |
| level 2: placebo | Placebo comparator | D1: 2400 mg BID; D2 to D13: 2000 mg BID and D14: 2000 mg in the morning Receives: Drug: Placebo |
| level 3: placebo | Placebo comparator | D1: 2400 mg BID; D2 to D13: 2400 mg BID andD14: 2400 mg in the morning Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance
Tolerance of high doses of favipiravir, defined by the number of participants with at least one adverse medical event considered as related to favipiravir (AER)-as determined and validated by the sponsor- clinical stage 3 or 4 according to the CTCAE (v5.0) not found at inclusion at same level and biological AER de stage 3 or 4 not found at inclusion in the same level. AER are collected daily until D15 and at D21 and D28, as well as at M3 and M6 for participating men.
D1 is the first day of favipiravir or placebo intake.
Measured: Months 6
Secondary outcomes (3)
Plasma concentration of favipiravir
Construction of the pharmacokinetic model and the estimation of its parameters will be realized by a population pharmacokinetic analysis integrating all available data on plasma concentration.
Measured: Day 1 (Hour 0; Hour 0.5 ; Hour 1; Hour 2; Hour 5; Hour 8), Day 3 (Hour 0 ; Hour 0.5; Hour 2), Day 7 (Hour 0; Hour 0.5 ; Hour 1; Hour 2; Hour 5; Hour 8), Day 10 (Hour 0), Day 14 (Hour 0; Hour 0.5 ; Hour 1; Hour 2; Hour 5; Hour 8), Day 15 (Hour 0)
Genetic
Genetic variants associated with favipiravir exposure. Targeted genotyping of variants of the gene encoding the enzyme responsible for transport and metabolism of favipiravir (aldehyde deshydrogenase) will be performed.
Measured: Days 1
Sperm pharmacology
For participating men: favipiravir concentration in sperm at D14 and D28.
Measured: Day 14, day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start14 May 2024
- Primary completionJun 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dose-escalation trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- FUJIFILM Toyama Chemical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Denis MALVY, Study chair, CHU de Bordeaux & INSERM, Université de Bordeaux, FranceXavier DUVAL, Principal investigator, APHP Hôpital Bichat Claude BernardJean-Jacques KILADJIAN, Study director, INSERM Pôle Recherche Clinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024421
- Sponsor's protocol ID
- C18-47
- Other IDs
- 2022-502871-49-00
- Acronym
- FAVIDOSE
- Status last verified
- Feb 2026
- First submitted
- 7 Jul 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION DE LA TOLERANCE ET DU PROFIL PHARMACOCINETIQUE DE DOSES ELEVEES DE FAVIPIRAVIR CHEZ LE VOLONTAIRE SAIN
- ClinicalTrials.gov ID
- NCT06024421
- Acronym / sponsor ID
- FAVIDOSE / C18-47
- Conditions
- Infectious Disease, Pharmacology
- Keywords
- healthy volunteer, dose escalation, tolerance, pharmacokinetics, favipiravir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- FUJIFILM Toyama Chemical Co., Ltd.
- Study start
- 14 May 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Dose-escalation trial
| Arm | Type | Receives |
|---|---|---|
| level 1: experimental | Experimental | Drug: favipiravirD1: 2400 mg BID; D2 to D13: 1600 mg BID and D14: 1600 mg in the morning |
| level 2: experimental | Experimental | Drug: favipiravirD1: 2400 mg BID; D2 to D13: 2000 mg BID and D14: 2000 mg in the morning |
| level 3: experimental | Experimental | Drug: favipiravirD1: 2400 mg BID; D2 to D13: 2400 mg BID andD14: 2400 mg in the morning |
| level 1: placebo | Placebo comparator | Drug: PlaceboD1: 2400 mg BID; D2 to D13: 1600 mg BID and D14: 1600 mg in the morning |
| level 2: placebo | Placebo comparator | Drug: PlaceboD1: 2400 mg BID; D2 to D13: 2000 mg BID and D14: 2000 mg in the morning |
| level 3: placebo | Placebo comparator | Drug: PlaceboD1: 2400 mg BID; D2 to D13: 2400 mg BID andD14: 2400 mg in the morning |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
- For women of childbearing potential: effective contraceptive method combining two methods of contraception (one female contraceptive method combined with male condom use) from the inclusion visit until 1 month after discontinuation of the investigational drug;
Key exclusion criteria (27 listed)
- 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
- History of hypersensitivity reaction to a nucleoside analog targeting viral RNA polymerase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| favipiravirLight yellow, film-coated tablet, each containing 200 mg of favipiravir | Drug | level 1: experimental, level 2: experimental, level 3: experimental |
| PlaceboLight yellow, film-coated tablet | Drug | level 1: placebo, level 2: placebo, level 3: placebo |
Primary outcome
Tolerance
Time frame: Months 6
Tolerance of high doses of favipiravir, defined by the number of participants with at least one adverse medical event considered as related to favipiravir (AER)-as determined and validated by the sponsor- clinical stage 3 or 4 according to the CTCAE (v5.0) not found at inclusion at same level and biological AER de stage 3 or 4 not found at inclusion in the same level. AER are collected daily until D15 and at D21 and D28, as well as at M3 and M6 for participating men. D1 is the first day of favipiravir or placebo intake.
3 secondary outcomes
Plasma concentration of favipiravir
Time frame: Day 1 (Hour 0; Hour 0.5 ; Hour 1; Hour 2; Hour 5; Hour 8), Day 3 (Hour 0 ; Hour 0.5; Hour 2), Day 7 (Hour 0; Hour 0.5 ; Hour 1; Hour 2; Hour 5; Hour 8), Day 10 (Hour 0), Day 14 (Hour 0; Hour 0.5 ; Hour 1; Hour 2; Hour 5; Hour 8), Day 15 (Hour 0)
Genetic
Time frame: Days 1
Sperm pharmacology
Time frame: Day 14, day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Denis MALVY study chair
CHU de Bordeaux & INSERM, Université de Bordeaux, France
Xavier DUVAL principal investigator
APHP Hôpital Bichat Claude Bernard
Jean-Jacques KILADJIAN study director
INSERM Pôle Recherche Clinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing favipiravir in people with Infectious Disease and Pharmacology, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cedric LAOUNAN (+33 1 40 25 79 31, cedric.laouenan@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance (time frame: Months 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.