To Evaluate the Adhesion of TK-254RX on Healthy Participants

NCT07307794 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: TK-254RX-01072025-523577-42-00
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, open-label, multiple-dose trial in healthy participants. The primary purpose of this study is to assess the adhesion of TK-254RX. Secondary purposes are to assess the safety of TK-254RX and the residual amount of the patch.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Characterization of the patch adhesion

  Measuring the patch adhesion area by percentage visually by site staff, with the patch remaining adhered

  Day 1 to Day 4

Secondary Outcomes (2)

• Recording adverse events and serious adverse events

  Day 1 to Day 4

• Residual amount of S-flurbiprofen

  Day 3 to Day 4

Study Arms (1)

TK-254RX

EXPERIMENTAL

TK-254RX will be applied to the left or right lower leg above the ankle once daily over 3 consecutive days

Drug: Esflurbiprofen Topical System

Interventions

Esflurbiprofen Topical System DRUG

The total of one TK-254RX per day for 3 days

TK-254RX

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age: 18 to 64 years
• good state of health
• 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 participants enrolled in the clinical trial

You may not qualify if:

• any injury of body which may induce the restriction of body movement
• excessively hairy skin at application site
• current or anamnestic known skin disorder (e.g., atopic dermatitis (eczema), neurodermatitis, contact allergy, psoriasis, vitiligo, melanoma, squamous cell carcinoma) or shaving hair at application site, which might interfere with the safety or tolerability of the active ingredient
• history of excessive sweating/hyperhidrosis inclusive of application site
• drug or alcohol abuse in the opinion of the investigator
• pregnant and lactating women
• women of child-bearing potential (WOCBP) who do not agree to apply highly effective contraceptive methods
• Surgical sterilization
• Hormonal contraception: combined (estrogen and progestogen containing) hormonal contraception, e.g., oral, intravaginal, transdermal, and progestogen-only hormonal contraception e.g. oral, injectable, implantable as well as intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) each in combination with male condom to increase safety effect (double barrier method))
• Bilateral tubal occlusion
• Total abstinence throughout the study at the discretion of the Investigator
• Periodic abstinence is not an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study.
• A woman who is post-menopausal and not surgically sterile must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of childbearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL or had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman had been confirmed by follow up hormone level assessment.
• known hypersensitivity to Esflurbiprofen, R-flurbiprofen or one of the excipients of the EFTS
• existing cardiac and/or hematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient

Sponsors & Collaborators

• Teikoku Seiyaku Co., Ltd.: lead
• SocraTec R&D GmbH: collaborator
• SocraMetrics GmbH: collaborator
• HWI pharma services GmbH: collaborator
• Clinsearch GmbH: collaborator
• CRM Biometrics GmbH: collaborator

Study Sites (1)

Deutsche Sporthochschule Köln

Am Sportpark Muengersdorf 6, Clogne, 50933, Germany

RECRUITING

Study Officials

• Kenichi Nishiyama

  Teikoku Seiyaku Co., Ltd.

  STUDY CHAIR

Central Study Contacts

Yoshiyuki Taneoka

CONTACT

+813-6264-9123; y-taneoka@teiyaku.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: January 19, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)