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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: TK-254RX

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Brühl, Germany
    • Medical Practice Ebert
  • Fürstenfeldbruck, Germany
    • Medical Practice Pabst
  • Gilching, Germany
    • Medical Practice Gastl
  • Rheinbach, Germany
    • Medical Pracitice Schaale/Bücheler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TK-254RX applied to Lower Arm, Lower thigh or Ankle; 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	Drug: TK-254RX; Two TK-254RX per day to predetermined application site
Experimental: TK-254RX applied to Upper Arm, Upper thigh or Lower leg; 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	Drug: TK-254RX; Two TK-254RX per day to predetermined application site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	5 minutes prior to removal,

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal
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).	before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal
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.	5minutes prior to removal
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.	within 5 minutes after removal of each patch

Collaborators and Investigators

• Sponsor: Teikoku Seiyaku Co., Ltd.
• Collaborators: ClinSearch; CRM Biometrics GmbH; SocraTec R&D GmbH; SocraMetrics GmbH; Clinigen Clinical Supplies Management GmbH
• Investigators: Study Chair: Kenichi Nishiyama, Teikoku Seiyaku Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Actual): November 9, 2023
• Study Completion (Actual): December 13, 2023

Study Registration Dates

• First Submitted: September 10, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: TK-254RX-0106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No