HealthyPhase 1NCT06870422
To Assess the Effect of the Special Condition on the Pharmacokinetics and Tolerability of the Esflurbiprofen Topical System (EFTS) in Healthy Volunteers.
A Phase 1 study testing Esflurbiprofen Topical System in people with Healthy, run by Teikoku Seiyaku Co., Ltd. at 1 site in Germany.
Trial summary
This study is a single-center, open-label, single-dose trial performed in a randomized, four-way, change-over design in healthy volunteers. The primary purpose of this study is to evaluate the effect of moderate heat, occlusion, and moderate exercise on pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Esflurbiprofen Topical System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- 28 Feb 2025to 14 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 18 to 64 years (inclusive)
- body-mass index (BMI): ≧18.5 kg/m² and ≦ 30.0 kg/m²
- good state of health
- non-smoker or ex-smoker for at least 6 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
Who cannot join
- existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- existing or history of hypertension and/or heart failure
- existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
- existing gastrointestinal diseases or pathological findings, which might interfere with the safety and tolerability of the active ingredient
- history of gastrointestinal bleeding or perforation related to previous NSAID therapy
- active, or history of ulcerative colitis, Crohn's disease, peptic ulceration or gastrointestinal haemorrhage
Show all 40Show fewer
- existing metabolic, endocrine and/or immunologic diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
- diabetes mellitus
- hyperlipidaemia (LDL > 4.16 mmol/l, HDL < 0.91 mmol/l, triglycerides > 2.28 mmol/l, cholesterol > 6.24 mmol/l)
- history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- presence or history of acute or chronic diseases of the skin (e.g., atopic dermatitis (eczema), neurodermatitis, contact allergy, psoriasis, vitiligo, melanoma, squamous cell carcinoma), any dermatological condition or skin sensitivity which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- existing or history of bronchial asthma
- known allergic reactions (e.g., bronchospasm, rhinitis, angioedema, or urticaria) to the active ingredients used, to acetylsalicylic acid or other NSAIDs, or to constituents of the pharmaceutical preparations
- history of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
- systolic blood pressure < 90 or > 139 mmHg
- diastolic blood pressure < 60 or > 89 mmHg
- heart rate < 50 bpm or > 90 bpm
- QTc interval > 450 ms for men and > 470 ms for women
- laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
- ASAT > 20% ULN, ALAT > 10% ULN, bilirubin > 20% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine > 0.1 mg/dL ULN (limit of > 0.1 mg/dL correspondents to of > 9 µmol/l ULN).
- positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test or anti-HCV-test
- vaccination against COVID-19 within the last 4 weeks prior to individual intended IMP application
- skin abnormality (e.g., tattoo (including tattoo that was removed), scar, sunburn, or obvious difference in skin colour), open sores, or excessive hair at the application site
- acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
- history of or current drug or alcohol dependence
- positive alcohol or drug test at screening examination
- regular intake of alcoholic food or beverages of ≥ 24 g pure ethanol for male or ≥ 12 g pure ethanol for female per day
- subjects who are on a diet which could affect the pharmacokinetics of the active ingredient
- regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
- blood donation or other blood loss of more than 400 ml within the last 2 months prior to individual enrolment of the subject
- participation in a clinical trial with administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the subject
- simultaneous participation in another clinical trial with active ingredients
- regular treatment with any systemically available medication (except sexual and thyroid hormones)
- subjects, who report a frequent occurrence of migraine attacks
- positive pregnancy test at screening examination
- pregnant or lactating women
- female subjects who do not agree to apply highly effective contraceptive methods
- 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 suspected or known not to follow instructions
- subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
SocraTec R&D GmbH Clinical Pharmacology Unit
Mainzerhofplatz, Erfurt, 99084
About this study
Official title: A Randomized, Four-way Change-over Study to Evaluate the Effect of Moderate Heat, Occlusion, and Moderate Exceise on the Pharmacokinetics and Tolerability of the Esflurbiprofen Topical System in Healthy Volunteers
This study is a single-center, open-label, single-dose trial performed in a randomized, four-way, change-over design in healthy volunteers. The primary purpose of this study is to evaluate the effect of moderate heat, occlusion, and moderate exercise on pharmacokinetics. The secondary purpose is to characterize the effect of special conditions on the bioavailability and to evaluate patch adhesion and safety of TK-254RX and a residual amount of the patch.
- Conditions
- Healthy
- Being tested
- Esflurbiprofen Topical System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esflurbiprofen Topical SystemDrug
TK-254RX will be applied for one day
| Study group | Role | What they receive |
|---|---|---|
| TK-254RX | Experimental | TK-254RX will be applied with no special condition Receives: Drug: Esflurbiprofen Topical System |
| TK-254RX with heat | Experimental | TK-254RX will be applied with moderate heat Receives: Drug: Esflurbiprofen Topical System |
| TK-254RX with occlusion | Experimental | TK-254RX will be applied with occlusion Receives: Drug: Esflurbiprofen Topical System |
| TK-254RX with exercise | Experimental | TK-254RX will be applied with 3 moderate exercise sessions Receives: Drug: Esflurbiprofen Topical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the effect of each intervention by Area under the plasma concentration versus time curve over 24 hours (AUC0-24) of S-flurbiprofen
assessment of the effect of heat, occlusion, and moderate exercise on Test by use of AUC0-24 of S flurbiprofen
Measured: Day 1 to Day 2 for each period
Assessing the effect of each intervention by peak plasma concentration (Cmax) of S-flurbiprofen
assessment of the effect of heat, occlusion, and moderate exercise on Test determined by use of Cmax of S flurbiprofen
Measured: Day 1 to Day 2 for each period
Assessing the effect of each intervention by area under the plasma concentration versus time curve from patch application to last measurement time point with a concentration value above lower limit of quantitation (AUC0-tlast) of S-flurbiprofen
assessment of the effect of heat, occlusion, and moderate exercise on Test determined by use of AUC0-tlast of S flurbiprofen
Measured: Day 1 to Day 4 for each period
Assessing the effect of each intervention by area under the plasma concentration versus time curve from patch application to infinity (AUC0-inf) of S-flurbiprofen
assessment of the effect of heat, occlusion, and moderate exercise on Test determined by use of AUC0-inf of S flurbiprofen
Measured: Day 1 to Day 4 for each period
Secondary outcomes (15)
Assessing the effect of each intervention by area under the curve over 24 hours (AUC0-24)
Characterisation of the effect of heat, occlusion, and moderate exercise on the bioavailability of Test determined by AUC0-24 of R-flurbiprofen and metabolites, if applicable
Measured: Day 1 to Day 2 for each period
Assessing the effect of each intervention by peak plasma concentration (Cmax)
Characterisation of the effect of heat, occlusion, and moderate exercise on the bioavailability of Test determined by Cmax of R-flurbiprofen and metabolites, if applicable
Measured: Day 1 to Day 2 for each period
Assessing the effect of each intervention by area under the plasma concentration versus time curve from patch application to last time point with a concentration value above lower limit of quantitation (AUC0-tlast)
Characterisation of the effect of heat, occlusion, and moderate exercise on the bioavailability of Test determined by AUC0-tlast of R-flurbiprofen and metabolites, if applicable
Measured: Day 1 to Day 4 for each period
Assessing the effect of each intervention by area under plasma concentration versus time curve from patch application to infinity (AUC0-inf)
Characterisation of the effect of heat, occlusion, and moderate exercise on the bioavailability of Test determined by AUC0-inf of R-flurbiprofen and metabolites, if applicable
Measured: Day 1 to Day 4 for each period
Assessing the effect of each intervention by percentage of area under the plasma concentration versus time curve extrapolated to infinity to area under the plasma concentration versus time curve from 0 hour to infinity (AUCexpol%)
characterisation of the effect of heat, occlusion, and moderate exercise on the bioavailability of Test determined by AUCexpol% of S flurbiprofen as well as R flurbiprofen and their metabolites, if applicable
Measured: Day 1 to Day 4 for each period
Assessing the effect of each intervention by concentration at the last time point with concentration value above lower limit of quantitation (Clast)
characterisation of the effect of heat, occlusion, and moderate exercise on the bioavailability of Test determined by Clast of S flurbiprofen as well as R flurbiprofen and their metabolites, if applicable
Measured: Day 1 to Day 2 for each period
Assessing the effect of each intervention by time point to reach peak plasma concentration (Tmax)
characterisation of the effect of heat, occlusion, and moderate exercise on the bioavailability of Test determined by Tmax of S flurbiprofen as well as R flurbiprofen and their metabolites, if applicable
Measured: Day 1 to Day 4 for each period
Asssessing the effect of each intervention by last time point with concentration value above the lower limit of quantitation (Tlast)
characterisation of the effect of heat, occlusion, and moderate exercise on the bioavailability of Test determined by Tlast of S flurbiprofen as well as R flurbiprofen and their metabolites, if applicable
Measured: Day 1 to Day 4 for each period
Assessing the effect of each intervention by apparent terminal elimination half-life (T1/2)
characterisation of the effect of heat, occlusion, and moderate exercise on the bioavailability of Test determined by T1/2 of S flurbiprofen as well as R flurbiprofen and their metabolites, if applicable
Measured: Day 1 to Day 4 for each period
Assessing the effect of each intervention by apparent terminal elimination rate constant determined by log-linear regression (Lz)
characterisation of the effect of heat, occlusion, and moderate exercise on the bioavailability of Test determined by Lz of S flurbiprofen as well as R flurbiprofen and their metabolites, if applicable
Measured: Day 1 to Day 4 for each period
Assessing the effect of each intervention by time point before first concentration balue above the lower limit quantitation (Tlag)
characterisation of the effect of heat, occlusion, and moderate exercise on the bioavailability of Test determined by Tlag of S flurbiprofen as well as R flurbiprofen and their metabolites, if applicable
Measured: Day 1 to Day 2 for each period
Characterization of EFTS adhesion
measuring patch adhesion area by percentage of visually by site staff with remaining patch adhered
Measured: Day 2 for each period
Characterization of local tolerability
Assessing the local tolerability by using the 8-point dermal response and other effects score according to FDA recommendation
Measured: with in 5 minutes after removal of each patch as well as 12 hours, 24 hours, and 36 hours after removal for each period
Recording adverse event and serious adverse event
Measured: Day 1 to Day 4 for each period
Residual amount
residual amout of S-flurbiprofen in used patch for each period
Measured: Day 2 for each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start28 Feb 2025
- Primary completion3 Apr 2025
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teikoku Seiyaku Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SocraTec R&D GmbH, SocraMetrics GmbH, HWI pharma services GmbH
- Responsible party
- Sponsor
- Investigators
- Kenichi Nishiyama, Study chair, Teikoku Seiyaku Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870422
- Sponsor's protocol ID
- TK-254RX-0104
- Other IDs
- 2024-513059-33-00
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Four-way Change-over Study to Evaluate the Effect of Moderate Heat, Occlusion, and Moderate Exceise on the Pharmacokinetics and Tolerability of the Esflurbiprofen Topical System in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06870422
- Acronym / sponsor ID
- TK-254RX-0104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Teikoku Seiyaku Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- SocraTec R&D GmbH, SocraMetrics GmbH, HWI pharma services GmbH
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-center, open-label, single-dose trial performed in a randomized, four-way, change-over design in healthy volunteers. The primary purpose of this study is to evaluate the effect of moderate heat, occlusion, and moderate exercise on pharmacokinetics. The secondary purpose is to characterize the effect of special conditions on the bioavailability and to evaluate patch adhesion and safety of TK-254RX and a residual amount of the patch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TK-254RX | Experimental | Drug: Esflurbiprofen Topical SystemTK-254RX will be applied with no special condition |
| TK-254RX with heat | Experimental | Drug: Esflurbiprofen Topical SystemTK-254RX will be applied with moderate heat |
| TK-254RX with occlusion | Experimental | Drug: Esflurbiprofen Topical SystemTK-254RX will be applied with occlusion |
| TK-254RX with exercise | Experimental | Drug: Esflurbiprofen Topical SystemTK-254RX will be applied with 3 moderate exercise sessions |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age: 18 to 64 years (inclusive)
- body-mass index (BMI): ≧18.5 kg/m² and ≦ 30.0 kg/m²
- good state of health
- non-smoker or ex-smoker for at least 6 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
Key exclusion criteria (40 listed)
- existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- existing or history of hypertension and/or heart failure
- existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
- existing gastrointestinal diseases or pathological findings, which might interfere with the safety and tolerability of the active ingredient
- history of gastrointestinal bleeding or perforation related to previous NSAID therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esflurbiprofen Topical SystemTK-254RX will be applied for one day | Drug | TK-254RX, TK-254RX with exercise, TK-254RX with heat, TK-254RX with occlusion |
Primary outcome
Assessing the effect of each intervention by Area under the plasma concentration versus time curve over 24 hours (AUC0-24) of S-flurbiprofen
Time frame: Day 1 to Day 2 for each period
assessment of the effect of heat, occlusion, and moderate exercise on Test by use of AUC0-24 of S flurbiprofen
Assessing the effect of each intervention by peak plasma concentration (Cmax) of S-flurbiprofen
Time frame: Day 1 to Day 2 for each period
assessment of the effect of heat, occlusion, and moderate exercise on Test determined by use of Cmax of S flurbiprofen
Assessing the effect of each intervention by area under the plasma concentration versus time curve from patch application to last measurement time point with a concentration value above lower limit of quantitation (AUC0-tlast) of S-flurbiprofen
Time frame: Day 1 to Day 4 for each period
assessment of the effect of heat, occlusion, and moderate exercise on Test determined by use of AUC0-tlast of S flurbiprofen
Assessing the effect of each intervention by area under the plasma concentration versus time curve from patch application to infinity (AUC0-inf) of S-flurbiprofen
Time frame: Day 1 to Day 4 for each period
assessment of the effect of heat, occlusion, and moderate exercise on Test determined by use of AUC0-inf of S flurbiprofen
15 secondary outcomes
Assessing the effect of each intervention by area under the curve over 24 hours (AUC0-24)
Time frame: Day 1 to Day 2 for each period
Assessing the effect of each intervention by peak plasma concentration (Cmax)
Time frame: Day 1 to Day 2 for each period
Assessing the effect of each intervention by area under the plasma concentration versus time curve from patch application to last time point with a concentration value above lower limit of quantitation (AUC0-tlast)
Time frame: Day 1 to Day 4 for each period
Assessing the effect of each intervention by area under plasma concentration versus time curve from patch application to infinity (AUC0-inf)
Time frame: Day 1 to Day 4 for each period
Assessing the effect of each intervention by percentage of area under the plasma concentration versus time curve extrapolated to infinity to area under the plasma concentration versus time curve from 0 hour to infinity (AUCexpol%)
Time frame: Day 1 to Day 4 for each period
Assessing the effect of each intervention by concentration at the last time point with concentration value above lower limit of quantitation (Clast)
Time frame: Day 1 to Day 2 for each period
Assessing the effect of each intervention by time point to reach peak plasma concentration (Tmax)
Time frame: Day 1 to Day 4 for each period
Asssessing the effect of each intervention by last time point with concentration value above the lower limit of quantitation (Tlast)
Time frame: Day 1 to Day 4 for each period
Assessing the effect of each intervention by apparent terminal elimination half-life (T1/2)
Time frame: Day 1 to Day 4 for each period
Assessing the effect of each intervention by apparent terminal elimination rate constant determined by log-linear regression (Lz)
Time frame: Day 1 to Day 4 for each period
Assessing the effect of each intervention by time point before first concentration balue above the lower limit quantitation (Tlag)
Time frame: Day 1 to Day 2 for each period
Characterization of EFTS adhesion
Time frame: Day 2 for each period
Characterization of local tolerability
Time frame: with in 5 minutes after removal of each patch as well as 12 hours, 24 hours, and 36 hours after removal for each period
Recording adverse event and serious adverse event
Time frame: Day 1 to Day 4 for each period
Residual amount
Time frame: Day 2 for each period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenichi Nishiyama study chair
Teikoku Seiyaku Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Esflurbiprofen Topical System in people with Healthy, run by Teikoku Seiyaku Co., Ltd. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the effect of each intervention by Area under the plasma concentration versus time curve over 24 hours (AUC0-24) of S-flurbiprofen (time frame: Day 1 to Day 2 for each period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.