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Evaluation of Tolerance and Pharmacokinetic Profile of High Doses of Favipiravir in Healthy Volunteers

NCT06024421 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-02-12

No results posted yet for this study

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. 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

Interventions

DRUG

favipiravir

Light yellow, film-coated tablet, each containing 200 mg of favipiravir

DRUG

Placebo

Light yellow, film-coated tablet

Sponsors & Collaborators

  • FUJIFILM Toyama Chemical Co., Ltd.

    collaborator INDUSTRY

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Principal Investigators

  • Denis MALVY · CHU de Bordeaux & INSERM, Université de Bordeaux, France

  • Xavier DUVAL · APHP Hôpital Bichat Claude Bernard

  • Jean-Jacques KILADJIAN · INSERM Pôle Recherche Clinique

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2027-06-30
Completion
2027-11-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06024421 on ClinicalTrials.gov