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

NCT06042192 | Completed Phase 1 FDA Drug

• 1 other identifier: TK-254RX-0106
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (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).

  5 minutes prior to removal,

Secondary Outcomes (4)

• Characterization of adhesion by visual estimation of subjects

  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

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

• Comparison of the adhesion assessments between subjects and study staff

  5minutes prior to removal

• Characterization of local tolerability during treatment

  within 5 minutes after removal of each patch

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

TK-254RX DRUG

Two TK-254RX per day to predetermined application site

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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Teikoku Seiyaku Co., Ltd.: lead
• ClinSearch: collaborator
• SocraTec R&D GmbH: collaborator
• SocraMetrics GmbH: collaborator
• CRM Biometrics GmbH: collaborator
• Clinigen Clinical Supplies Management GmbH: collaborator

Study Sites (4)

Medical Practice Ebert

Brühl, Germany

Location

Medical practice Pabst

Fürstenfeldbruck, Germany

Location

Medical practice Gastl

Gilching, Germany

Location

Medical Pracitice Schaale/Bücheler

Rheinbach, Germany

Location

Study Officials

• Kenichi Nishiyama

  Teikoku Seiyaku Co., Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 18, 2023
• Study Start: September 14, 2023
• Primary Completion: November 9, 2023
• Study Completion: December 13, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)