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

Primary Purpose

Healthy

Status
Not yet recruiting
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
TK-254RX
Sponsored by
Teikoku Seiyaku Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Medical Practice Ebert
  • Medical practice Pabst
  • Medical practice Gastl
  • Medical Pracitice Schaale/Bücheler

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

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

Arm 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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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.
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.

Full Information

First Posted
September 10, 2023
Last Updated
September 14, 2023
Sponsor
Teikoku Seiyaku Co., Ltd.
Collaborators
ClinSearch, SocraTec R&D GmbH, SocraMetrics GmbH, CRM Biometrics GmbH, Clinigen Clinical Supplies Management GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT06042192
Brief Title
Open Label Trial to Evaluate the Adhesion of TK-254RX in Healthy Volunteers.
Official Title
Open Label Trial to Evaluate the Adhesion of TK-254RX in Healthy Volunteers.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 18, 2023 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teikoku Seiyaku Co., Ltd.
Collaborators
ClinSearch, SocraTec R&D GmbH, SocraMetrics GmbH, CRM Biometrics GmbH, Clinigen Clinical Supplies Management GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TK-254RX applied to Lower Arm, Lower thigh or Ankle
Arm Type
Experimental
Arm 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
Arm Title
TK-254RX applied to Upper Arm, Upper thigh or Lower leg
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
TK-254RX
Intervention Description
Two TK-254RX per day to predetermined application site
Primary Outcome Measure Information:
Title
Characterization of adhesion 5 minutes prior to removal by the adhesion assessment by site staff with EFTS marked by site staff
Description
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).
Time Frame
5 minutes prior to removal,
Secondary Outcome Measure Information:
Title
Characterization of adhesion by visual estimation of subjects
Description
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.
Time Frame
before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal
Title
Characterization of adhesion by the adhesion assessment by site staff with EFTS marked by subjects
Description
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).
Time Frame
before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal
Title
Comparison of the adhesion assessments between subjects and study staff
Description
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.
Time Frame
5minutes prior to removal
Title
Characterization of local tolerability during treatment
Description
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.
Time Frame
within 5 minutes after removal of each patch

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hirofumi Fujiwara, Master
Phone
+81362649123
Email
hirofumi-fujiwara@teiyaku.co.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenichi Nishiyama
Organizational Affiliation
Teikoku Seiyaku Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Practice Ebert
City
Brühl
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans-Georg Predel, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Eduard Ebert, Dr.
Facility Name
Medical practice Pabst
City
Fürstenfeldbruck
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helmut Pabst, Dr.
Facility Name
Medical practice Gastl
City
Gilching
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Gastl
Facility Name
Medical Pracitice Schaale/Bücheler
City
Rheinbach
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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