Single Ascending-dose Study of Injectable Favipiravir

JRCT ID: jRCT2071210042

Registered date:12/07/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: severe fever with thrombocytopenia syndrome
• Date of first enrollment: 27/07/2021
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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.

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 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

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 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

Related Information

• Primary Sponsor: Sakurai Tsutomu