To Evaluate the Adhesion of TK-254RX on Healthy Participants
NCT ID: NCT07307794
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1
90 participants
INTERVENTIONAL
2026-01-31
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TK-254RX
TK-254RX will be applied to the left or right lower leg above the ankle once daily over 3 consecutive days
Esflurbiprofen Topical System
The total of one TK-254RX per day for 3 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Esflurbiprofen Topical System
The total of one TK-254RX per day for 3 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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 (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
* 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
* ECG assessment by investigator: "conspicuous"
* participants who use any impermissible treatment or for whom restrictions apply
* subject is vulnerable such as detained or committed to an institution by a court of law or by legal authorities or close affiliation with the sponsor or the investigational site (e.g., a close relative of the investigator, dependent person (e.g., employee of or student at the investigational site), employee of the sponsor or affiliates)
* subjects who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
* subject with known bronchial asthma from previous history
* Laboratory values are out of normal range
18 Years
64 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SocraTec R&D GmbH
OTHER
SocraMetrics GmbH
INDUSTRY
HWI pharma services GmbH
INDUSTRY
Clinsearch GmbH
UNKNOWN
CRM Biometrics GmbH
INDUSTRY
Teikoku Seiyaku Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kenichi Nishiyama
Role: STUDY_CHAIR
Teikoku Seiyaku Co., Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Deutsche Sporthochschule Köln
Am Sportpark Muengersdorf 6, Clogne, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hans-Georg Predel, Prof. Dr.
Role: primary
Eduard Ebert, Dr.
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-523577-42-00
Identifier Type: CTIS
Identifier Source: secondary_id
TK-254RX-0107
Identifier Type: -
Identifier Source: org_study_id