severe fever with thrombocytopenia syndrome
Conditions
Interventions
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: F
Sponsors
Sakurai Tsutomu
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability (1) Adverse events (2) Laboratory tests (3) Vital signs (4) Twelve-lead electrocardiogram | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactOfficer Clinical Trial Information
FUJIFILM Toyama Chemical Co., Ltd.
Outcome results
None listed