A phase 1 open-label study evaluating the effects of food on TAS-205 in healthy volunteers

JRCT ID: jRCT2071230028

Registered date:25/06/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Duchenne Muscular Dystrophy
• Date of first enrollment: 20/07/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Orally administer 1600mg of TAS-205 fasting or after meals. After the washout period, orally administer 1600mg of TAS-205 again by crossover

Outcome(s)

• Primary Outcome: Pharmacokinetic parameters [Cmax, AUClast, AUCinf]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

(1) Healthy adult male subjects who provided written informed consent to participate in the study
(2) Aged 18 years or older and younger than 40 years at the time of informed consent
(3) Body weight of 60 kg or more and body mass index of 18.5 or more and less than 25.0 at the time of screening tests
(4) Capable of oral intake.

Exclude criteria

(1) Had current or previous hypersensitivity or allergy to drugs
(2) Had current or previous drug abuse (including use of illicit drugs) or alcoholism
(3) Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded)
(4) Consumed foods or beverages containing pomegranate, pomelo, star fruit, or vegetables of the family mustard (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard) within 7 days before study drug administration
(5) Consumed foods or beverages containing grapefruit or bitter orange within 14 days before study drug administration
(6) Consumed foods or beverages containing the St. John's Wort within 28 days before study drug administration
(7) Consumed fruit juices other than 4), 5), and 6) within 72 hours before study drug administration
(8) Consumed foods or beverages containing alcohol or caffeine within 72 hours before study drug administration

Related Information

• Primary Sponsor: Takeda Shin'ichi