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HealthyPhase 1NCT06042192

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

A Phase 1 study testing TK-254RX in people with Healthy, run by Teikoku Seiyaku Co., Ltd. at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. 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?
TK-254RX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
4 sitesGermany
Study dates
14 Sep 2023to 13 Dec 2023
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
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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 locations and contacts

4 sites in 1 country.

Germany4 sites

  • Medical Practice Ebert

    Brühl

  • Medical practice Pabst

    Fürstenfeldbruck

  • Medical practice Gastl

    Gilching

  • Medical Pracitice Schaale/Bücheler

    Rheinbach

Other trials in Germany

About this study

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.

Conditions
Healthy
Being tested
TK-254RX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TK-254RXDrug

    Two TK-254RX per day to predetermined application site

Study groups in NCT06042192
Study groupRoleWhat they receive
TK-254RX applied to Lower Arm, Lower thigh or AnkleExperimentalFor 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
Receives: Drug: TK-254RX
TK-254RX applied to Upper Arm, Upper thigh or Lower legExperimentalFor 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
Receives: Drug: TK-254RX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Characterization of adhesion 5 minutes prior to removal by the adhesion assessment by site staff with EFTS marked by site staff

    Assessment/estimation by site staff with marked TK-254RX by site staff: A listing of individual values of percentage will be presented per time point and subject.

    Descriptive statistics (Number, arithmetic mean, standard deviation, median, minimum and maximum) will be presented per time point for adhesion marker assessment by site staff with marked TK-254RX by site staff (percentage values).

    Measured: 5 minutes prior to removal,

Secondary outcomes (4)

  1. Characterization of adhesion by visual estimation of subjects

    Visual Assessment by subjects with a 5 point-scale: A listing of classification (≥90%, ≥75% to <90%, ≥50% to <75%, >0% to <50%, completely detached) of adhesion per time point and subject will be given.

    Measured: before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal

  2. Characterization of adhesion by the adhesion assessment by site staff with EFTS marked by subjects

    Assessment/estimation by site staff with marked TK-254RX by subject:

    A listing of individual values of percentage will be presented per time point and subject.

    Descriptive statistics (Number, arithmetic mean, standard deviation, median, minimum and maximum) will be presented per time point for adhesion marker assessment by site staff with marked TK-254RX by subject (percentage values).

    Measured: before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal

  3. Comparison of the adhesion assessments between subjects and study staff

    Three different adhesion assessments at 24hours as below will be performed. i. Visual assessment scale by subject ii. Assessment scale by site staff with marked TK-254RX by subject iii. Assessment scale by site staff with marked TK-254RX by site staff Comparison of i versus iii: the marked TK-254RX %-scale from iii are transformed into the 5-point scale (≥ 90%, ≥75% to <90%, ≥50% to <75%, >0% to <50%, completely detached); then the 5-point scale assessments from i and iii are compared via 5x5-cross tabulations and Spearman rank correlations.

    Comparison of ii versus iii: the marked TK-254RX %-scale from ii and iii are transformed into the 5-point scale (≥ 90%, ≥75% to <90%, ≥50% to <75%, >0% to <50%, completely detached); then the 5-point scale assessments from ii and iii are compared via 5x5-cross tabulations and Spearman rank correlations.

    Measured: 5minutes prior to removal

  4. Characterization of local tolerability during treatment

    The skin will be visually checked and palpated for skin irritation or sensitization by trained personnel.

    Local tolerability will be assessed by the Investigator according to FDA recommendations.

    Measured: within 5 minutes after removal of each patch

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2023
  2. Study start14 Sep 2023
  3. Primary completion9 Nov 2023
  4. Study completion13 Dec 2023

Resources

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
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06042192
Sponsor's protocol ID
TK-254RX-0106
Status last verified
Jan 2024
First submitted
10 Sep 2023
Last updated
12 Apr 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TK-254RX in people with Healthy, run by Teikoku Seiyaku Co., Ltd. at 4 sites 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 4 inclusion and 19 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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Characterization of adhesion 5 minutes prior to removal by the adhesion assessment by site staff with EFTS marked by site staff (time frame: 5 minutes prior to removal,). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06042192.

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 12 Apr 2024.

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