Clinical trial NCT06042192: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Teikoku Seiyaku Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: ClinSearch
name: SocraTec R&D GmbH
name: SocraMetrics GmbH
name: CRM Biometrics GmbH
name: Clinigen Clinical Supplies Management GmbH
First posted: 2023-09-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Characterization of adhesion 5 minutes prior to removal by the adhesion assessment by site staff with EFTS marked by site staff
timeFrame: 5 minutes prior to removal,
Secondary outcomes:
measure: Characterization of adhesion by visual estimation of subjects
timeFrame: before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal
measure: Characterization of adhesion by the adhesion assessment by site staff with EFTS marked by subjects
timeFrame: before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal
measure: Comparison of the adhesion assessments between subjects and study staff
timeFrame: 5minutes prior to removal
measure: Characterization of local tolerability during treatment
timeFrame: within 5 minutes after removal of each patch
Other outcomes:
Locations:
city: Brühl
country: Germany
facility: Medical Practice Ebert
city: Fürstenfeldbruck
country: Germany
facility: Medical practice Pabst
city: Gilching
country: Germany
facility: Medical practice Gastl
city: Rheinbach
country: Germany
facility: Medical Pracitice Schaale/Bücheler
Study officials:
affiliation: Teikoku Seiyaku Co., Ltd.
name: Kenichi Nishiyama
role: STUDY_CHAIR
References: