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Official title Evaluation of Tolerance and Pharmacokinetic Profile of High Doses of Favipiravir in Healthy Volunteers
ClinicalTrials.gov ID: NCT06024421
What this study is testing
What is favipiravir?
favipiravir is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for infectious disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- Concomitant use or within 15 days prior to inclusion of another QT/QTc prolonging drug or drugs that may disrupt electrolyte levels, among others...
- 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)
See the full eligibility criteria
- 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...
- Blood chemistry:
- 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...
- 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.
- 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...
- 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)
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.