A Clinical trial for Resminostat to Investigate the Effect of Food

Phase 1

• Conditions: Cutaneous T cell lymphoma

• Registration Number: JPRN-jRCT2071210134
• Lead Sponsor: Asami Tsubasa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 12

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

-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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PK: Pharmacokinetic parameters

Secondary Outcome Measures

Name	Time	Method
Safety: Type, frequency, and severity of adverse events and adverse drug reactions