Healthy adult male
Conditions
Interventions
Study Drug Application for Subjects
Phase I: Apply one LC2701 patch for 24 hours on Day 1. Washout Period: At least 7 days. Phase II: Apply two LC2701 patches for 24 hours on Day 1. The study drug wil
Sponsors
Yamamoto Yoshihiro
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Screening Criteria 1.Age: Male aged between 18 and 65 years old. 2.BMI: Body Mass Index (BMI) between 18.5 kg/m2 and 30.0 kg/m2 (no rounding). 3.Non-smokers 4.Eligibility: Judged eligible by the principal investigator or sub-investigator based on the screening test results. 5.Exercise Restriction: Able to refrain from excessive exercise that causes sweating during the admission period. 6.Blood Sampling: Able to undergo blood sampling according to the study protocol. 7.Consent: Voluntarily agrees to participate in the study (including screening tests) after receiving a thorough explanation of the study drug and the study's purpose and content, and provides written consent. Inclusion criteria before the start of the study drug (1) Those who the principal investigator (subinvestigator) judges to be eligible as study subjects for this study, taking into consideration the results of tests and examinations before the start of the study drug
Exclusion criteria
Exclusion criteria: [Exclusion criteria for screening tests] (1) Those with hypersensitivity or specific constitution to drugs, etc. (2) Those with liver disease that affects drug metabolism (3) Those with skin wounds at the site where the study drug is applied, or those with skin symptoms such as eczema, contact dermatitis, psoriasis, seborrheic dermatitis, pigmentation disorders, or excessive sunburn at the site where the study drug is applied (4) Those with or with a history of allergic skin diseases (drugs, metals, etc.) (5) Current smokers (6) Those with alcoholism or with drug addiction (7) Persons who have used medicines (excluding artificial tears) within one week prior to the planned start date of the study drug application (8) Persons who have had the stratum corneum of the chest skin peeled off within three months prior to the planned start date of the study drug application (9) Persons who have received ramelteon, fluvoxamine maleate, or flunitrazepam within two weeks prior to the planned start date of the study drug application (10) Persons who have received an investigational drug, etc. in another clinical trial within three months prior to the planned start date of the study drug application (11) Persons who have had more than 400 mL of whole blood drawn within three months before the start of study drug application, or those who have had more than 200 mL of whole blood or component blodd drawn within two months before the starat of study drug application. (12) Others who the principal investigator (subinvestigator) judges to be inappropriate. [Exclusion criteria before the start of study drug application] (1) Those who have skin wounds at the site where the study drug is applied, or those who have skin symptoms such as eczema, contact dermatitis, psoriasis, seborrheic dermatitis, pigmentation disorders, or excessive sunburn at the site where the study drug is applied. (2) Those who have used medicines (excluding artificial tears) within one week before the start of study drug application. (3) Those who have had the stratum corneum of the chest skin peeled off within three months before the start of study drug application. (4) Those who have been administered ramelteon, fluvoxamine maleate, or flunitrazepam within two weeks before the start of study drug application. (5) Those who have been administered an investigational drug in another clinical trial within three months before the start of study drug application. (6) Those who have had more than 400 mL of whole blood drawn within three months before the start of study drug application, or those who have had more than 200 mL of whole blood or component blodd drawn within two months before the starat of study drug application. (7) Subjects who have had a positive result to a SARS-CoV-2 antigen test or influenza antigen test within 14 days prior to the start of the study drug administration. (8) Subjects who are otherwise deemed inappropriate by the principal investigator (subinvestigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Concentration of Ramelteon and M-II Pharmacokinetic Parameters Maximum Plasma Concentration (Cmax) Time to Reach Maximum Plasma Concentration (Tmax) Area Under the Plasma Concentration-Time Curve from 0 to 28 hours (AUC0-28) Area Under the Plasma Concentration-Time Curve from 0 hours to Infinity (AUC0-infinity) Elimination Half-Life (t1/2) Elimination Rate Constant (kel) Concentration at the End of the Application Interval (CT) Mean Residence Time from 0 to 28 hours (MRT0-28) Apparent Plasma Clearance (CL/F) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Symptoms and objective findings Vital signs Electrocardiogram Clinical tests | — |
Contacts
Public ContactKeisuke Okabe
Toyama University Hospital
Outcome results
None listed