A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject

Condition(s) targeted: Healthy

Intervention: Topical steroid (Dexamethasone) (Drug); Topical antihistamine (Diphenhydramine) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Otsuka Pharmaceutical Co., Ltd.

Official(s) and/or principal investigator(s):
Kyoji Imaoka, Mr, Study Director, Affiliation: Otsuka Pharmaceutical Co., Ltd.

To investigate the efficacy of symptomatic therapy with topical steroids and antihistamines for application site reaction (ASR) after administration of SPM 962 in healthy subjects

Official title: An Open-Label Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Skin Irritation Score of the Application Site

Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)

Secondary outcome:

Skin Irritation Score After Patch Removal

Itching of Application Site Evaluated by VAS After Patch Removal

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject is a male or female and aged between 20 and 45 years of age (inclusive)

- Subject is of normal body weight as determined by a body-mass index (BMI) between 18

and 28 kg/m2

- Subject is healthy as determined by EA (medical history, physical examination, skin

evaluation, vital signs, ECG, hematology, clinical chemistry, urinalysis)

- Subject is surgically sterile; subject has been postmenopausal for at least 12

consecutive months if female; or subject agrees to remain abstinent or to follow two acceptable methods of birth control from EA to the end of observation period. (fore male and female subjects) Exclusion Criteria:

- Subject has a history or complication of epilepsy and/or seizures

- Subject has clinically relevant changes in the ECG, such as second- or third-degree

AV block, a complete bundle branch block, prolongation of the QRS complex over 120 ms, or of the QTcB (QT interval corrected for HR by Bazett´s formula) over 500 ms at EA

- Subject has a clinically relevant hepatic dysfunction

- Subject has a clinically relevant renal dysfunction

- Subject has a history of significant skin hypersensitivity to adhesives or other

transdermal products or recent unresolved contact dermatitis

- Subject has a history or complication of atopic or eczematous dermatitis, psoriasis,

and/or an active skin disease or skin tumors

- Subject has more than 1 known or suspected drug hypersensitivity, in particular to

any component of the trial medication

- Subject has a history of chronic alcohol or drug abuse within the last 5 years

- Subject is tested positive for HIV-1/2Ab, HBsAg or HCV-Ab

- Subject tests positive for alcohol and/or drugs at EA

- Subject is taking any prohibited concomitant medication

- Subject has a history or complication of narrow angle glaucoma

- Subject has a history or complication of respiratory or cardiovascular disorders

(e. g., heart failure, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction)

- Subject has a history or complication of psychic abnormality, psychiatric or

neurologic illness, or autonomic neuropathy

- Subject has a history or complication of diabetes mellitus and/or thyroid

dysfunction, especially hyperthyroidism or other endocrine disorders

- Subject has a history or complication of malignancy

Seoul National University Bundang Hospital, Kyeonggi-do, Korea, Republic of

Seoul National University Hospital, Seoul, Korea, Republic of

Starting date: August 2012
Last updated: March 26, 2014