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

Single Ascending-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

Officer Clinical Trial Information

FUJIFILM Toyama Chemical Co., Ltd.

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

+81-3-6228-3129

fftc-clinicaltrial-info1@fujifilm.com

Not Recruiting

July. 12, 2021

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 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 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

Investigational drug (T-705IV)
A single dose of injectable favipiravir (300-2400 mg) will be administered intravenously over 60 or 120 minutes.
Control drug (placebo)
A single dose of isotonic sodium chloride solution will be administered intravenously over 60 or 120 minutes.

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 of favipiravir and its metabolite (M1)
(2) Urinary excretion rate of favipiravir and M1
(3) PK parameters of favipiravir and M1 by non-compartmental analysis
(4) Dose proportionality of PK of favipiravir using Cmax and AUCinf

+81-92-283-7701

July. 09, 2021

No

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