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An Open-label, One-sequence Crossover Study of Favipiravir to Evaluate the Effects on the Pharmacokinetics of Triazolam/Metformin Hydrochloride in Healthy Adult Subjects

An Open-label, One-sequence Crossover Study of Favipiravir to Evaluate the Effects on the Pharmacokinetics of Triazolam/Metformin Hydrochloride in Healthy Adult Subjects

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

Mar. 30, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single 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, are able to provide written informed consent, and confirmed the intention to continue participating in the study

(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: Triazolam 0.25 mg will be administered orally once daily.
Day 3: Favipiravir 1800 mg will be administered orally twice daily.
Day 4: Favipiravir 800 mg will be administered orally twice daily and Triazolam 0.25 mg will be administered orally once daily.
Cohort 2
Day 1: Metformin Hydrochloride 250 mg will be administered orally once daily.
Day 3: Favipiravir 1800 mg will be administered orally twice daily.
Day 4: Favipiravir 800 mg will be administered orally twice daily and Metformin Hydrochloride 250 mg will be administered orally once daily.

To evaluate the pharmacokinetics
(1) Plasma concentration versus time profile and plasma PK parameters of triazolam (Cohort 1)
(2) Geometric mean ratios of Cmax, AUC0-t and AUCinf of triazolam in combination with favipiravir compared with those of triazolam alone and their 90% confidence intervals (Cohort 1)
(3) Plasma concentration versus time profile and plasma PK parameters of metformin (Cohort 2)
(4) Geometric mean ratios of Cmax, AUC0-t and AUCinf of metformin in combination with favipiravir compared with those of metformin alone and their 90% confidence intervals (Cohort 2)
(5) Plasma concentration versus time profile and plasma PK parameters of favipiravir and favipiravir hydroxide metabolite (M1) (Cohort 1 and 2)

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

+81-3-5366-3006

No

none