Duchenne Muscular Dystrophy
Conditions
Interventions
Orally administer 1600mg of TAS-205 fasting or after meals. After the washout period, orally administer 1600mg of TAS-205 again by crossover
Sponsors
Takeda Shin'ichi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters [Cmax, AUClast, AUCinf] | — |
Contacts
Public ContactKeita Watanabe
Taiho Pharmaceutical Co., Ltd.
Outcome results
None listed