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A Phase I, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Injectable Favipiravir in Healthy Subjects

Multiple-dose Study of Injectable Favipiravir

Sakurai Tsutomu

FUJIFILM Toyama Chemical Co., Ltd.

2-14-1, Kyoubashi, Chuo-ku, Tokyo, Japan

fftc-clinicaltrial-info1@fujifilm.com

Clinical Trial Information Officer

FUJIFILM Toyama Chemical Co., Ltd.

2-14-1, Kyoubashi, Chuo-ku, Tokyo, Japan

+81-3-6228-3129

fftc-clinicaltrial-info1@fujifilm.com

Not Recruiting

Feb. 28, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

(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

(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

Male

severe fever with thrombocytopenia syndrome

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.

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

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

+81-92-283-7701

Feb. 25, 2022

No

none