Fasudil trial phase 1 study(FAS1)

JRCT ID: jRCTs041210145

Registered date:14/02/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy
• Date of first enrollment: 16/11/2022
• Target sample size: 6
• Study type: Interventional

Intervention(s)

Cohort 1: fasudil hydrochloride 15mg once orally after breakfast
Cohort 2: fasudil hydrochloride 30mg once orally after breakfast

Outcome(s)

• Primary Outcome: To measure the blood concentration of M3 (active metabolite of fasudil) from 0 and to 6 hours after taking fasudil
• Secondary Outcome: Early allergic reaction, adverse effect such as hypotension

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 60age old
• Gender: Both

Include criteria

1) healthy volunteers
2) age from 20 to 60, weight from 50kg and more, body mass index from 15 to 30 kg/m2
3) perfomance status is 0
4) persons with written informed consent
5) volunteers response to Student bulletin board or request by volunteer introduction companies

Exclude criteria

1) persons with allergy against fasudil or nitrate
2) peasons with allergy for fasudil, pregnancy or breastfeeding
3) persons with diabetes mellitus, renal dysfunction, liver dysfunction, smoking, obesity, allergic disease
4) persons who study groups consider inappropriate for this study

Related Information

• Primary Sponsor: Okamoto Ryuji