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

JRCT ID: jRCT2031220735

Registered date:30/03/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: severe fever with thrombocytopenia syndrome
• Date of first enrollment: 30/03/2023
• Target sample size: 24
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

Primary Outcome

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)

Secondary Outcome

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

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

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 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

Related Information

• Primary Sponsor: Sakurai Tsutomu