Cutaneous T cell lymphoma
Conditions
Interventions
Using the crossover method of 2 groups x 2 periods, Resminostat is orally administered under fasted and fed conditions in an open-label manner.
Sponsors
Asami Tsubasa
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Caucasian males aged between 20 (inclusive) and 45 years of age (inclusive) at the time informed consent is obtained. -Body Mass Index between 18.5 kg/m2 (inclusive) and 30.0 kg/m2 (inclusive) at the time informed consent is obtained. -Written informed consent obtained from the subject.
Exclusion criteria
Exclusion criteria: -Clinical significant medical history or concomitant disease of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder. -History of surgery, such as gastrectomy, gastrointenstinal suture, or intenstinal resection that would potentially alter absorption of drugs. However, the history of appendicectomy is acceptable. -History of clinically significant hypersensitivity or allergy to any drugs or foods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK: Pharmacokinetic parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Type, frequency, and severity of adverse events and adverse drug reactions | — |
Contacts
Public ContactDevelopment Clinical
Yakult Honsha Co., Ltd.
Outcome results
None listed