A Clinical trial for Resminostat to Investigate the Effect of Food

JRCT ID: jRCT2071210134

Registered date:17/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cutaneous T cell lymphoma
• Date of first enrollment: 03/04/2022
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Using the crossover method of 2 groups x 2 periods, Resminostat is orally administered under fasted and fed conditions in an open-label manner.

Outcome(s)

• Primary Outcome: PK: Pharmacokinetic parameters
• Secondary Outcome: Safety: Type, frequency, and severity of adverse events and adverse drug reactions

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Asami Tsubasa