Open Label Trial to Evaluate the Adhesion of TK-254RX in Healthy Volunteers.

Teikoku Seiyaku

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: TK-254RX

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06042192

TK-254RX-0106

Details and patient eligibility

About

This study is a multi center, multiple dose, open label trial to evaluate the adhesion of TK-254RX in healthy volunteers. The primary purpose of this study is to evaluate the adhesion of TK-254RX. Secondary purpose is to show TK-254RX is safe and to explore and compare adhesion assessment methods.

Enrollment: 80 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age: 18 to 64 years
• good state of health
• non-smoker or ex-smoker for at least 3 months
• written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial

Exclusion criteria

The following must not apply:

• any injury of body which may induce the restriction of body movement
• excessively hairy skin at application site
• current skin disorder or shaving hair at application site
• history of excessive sweating/hyperhidrosis inclusive of application site
• participation in a clinical study within 30 days before inclusion in the study or concomitantly
• drug or alcohol abuse in the opinion of the investigator
• pregnant and lactating women
• women of child-bearing potential who do not agree to apply highly effective contraceptive methods
• known hypersensitivity to active ingredient, its racemate or one of the excipients of the TK-254RX
• existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
• existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
• known liver or kidney insufficiency
• existing gastrointestinal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
• history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
• systolic blood pressure < 90 or > 139 mmHg
• diastolic blood pressure < 60 or > 89 mmHg
• pulse rate < 50 bpm or > 90 bpm
• subjects who use any impermissible medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

TK-254RX applied to Lower Arm, Lower thigh or Ankle

Experimental group

Description:

For Group1, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects. Day1: Lower Arm, Day2: Lower thigh, Day3: Ankle

Treatment:

Drug: TK-254RX

TK-254RX applied to Upper Arm, Upper thigh or Lower leg

Experimental group

Description:

For Group2, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects. Day1: Upper Arm, Day2: Upper thigh, Day3: Lower leg

Treatment:

Drug: TK-254RX