Multiple-dose Study of Injectable Favipiravir

JRCT ID: jRCT2071210126

Registered date:04/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: severe fever with thrombocytopenia syndrome
• Date of first enrollment: 25/03/2022
• Target sample size: 24
• Study type: Interventional

Intervention(s)

Cohort 1
Day 1: Favipiravir 1800 mg or its placebo will be administered intravenously twice daily.
Day 2-10: Favipiravir 800 mg or its placebo will be administered intravenously twice daily.
Day 11: Favipiravir 800 mg or its placebo will be administered intravenously once daily.

Cohort 2
Day 1: Favipiravir 1800 mg or its placebo will be administered intravenously twice daily.
Day 2-5: Favipiravir 800 mg or its placebo will be administered intravenously twice daily.
Day 6-10: Favipiravir 800 mg or its placebo will be administered orally twice daily.
Day 11: Favipiravir 800 mg or its placebo will be administered orally once daily.

Outcome(s)

Primary Outcome

To evaluate the safety and tolerability
(1) Adverse events
(2) Laboratory tests
(3) Vital signs
(4) Twelve-lead electrocardiogram

Secondary Outcome

To evaluate the pharmacokinetics
(1) Plasma concentration versus time profile and plasma PK parameters of favipiravir and favipiravir hydroxide metabolite (M1)
(2) Urine PK parameters of favipiravir and M1
(3) Prediction of favipiravir plasma concentration by simulation using a mechanism based inhibition pharmacokinetics (MBI-PK) model
(4) Cmax, Cmin, daily AUC and cumulative AUC for each dosing day using MBI-PK model
(5) Attainment day of steady state

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 39age old
• Gender: Male

Include criteria

(1) Subjects between 20 and 39 years of age (inclusive) at informed consent
(2) Gender: Male subjects
(3) Subjects with BMI in the range of 18.5 or more and less than 30.0 kg/m2 and body weight 55 kg or more
(4) Subjects who understand the objectives of the study, volunteer to participate in the study, and are able to provide written informed consent

Exclude criteria

(1) Subjects with a medical history of gastrointestinal, skin, renal, hepatic, neurological, hematological, endocrine, cancer, respiratory, immunological, psychological, cardiovascular, or other diseases that is considered to affect safety of the subjects and evaluation of pharmacokinetics/safety of the study drug by the principal investigator or subinvestigator
(2) Subjects with a history of surgery or a disease condition that is considered by the principal investigator or subinvestigator to affect the absorption, distribution, metabolism, and excretion of the study drug
(3) Subjects who have previously received favipiravir
(4) Subjects who are deemed to be ineligible for the study by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Sakurai Tsutomu