Repeated dose study of NPC-22

JRCT ID: jRCT2031210169

Registered date:29/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Sialorrhea
• Date of first enrollment: 03/07/2021
• Target sample size: 16
• Study type: Interventional
• Intervention(s): Transdermal administration of NPC-22 or placebo once daily for 7 days

Outcome(s)

• Primary Outcome: Safety: Adverse events, skin findings (based on the assessment criteria developed by the Japanese Study Group for Patch Testing), vital signs, 12-lead electrocardiogram (ECG) , laboratory test values and C-SSRS

Secondary Outcome

Pharmacodynamics: Amount of salivation, salivation scores (assessed by subjects on the visual analog scale [VAS])
Pharmacokinetics: Plasma concentration of unchanged scopolamine, amount of excretion in the urine, the urine excretion rate and pharmacokinetic parameters (e.g., Cmax, C24h, tmax, AUC0-t and t1/2)
Others: Amount of the drug remaining in the products that are collected after administration of NPC-22 Tape and adhesion state of NPC-22 Tape

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1) Subjects who have provided their own written informed consent
2) Subjects aged >=20 and <40 years at the time of informed consent
3) Subjects with body weight of >=50 kg and body mass index (BMI) (kg/m2) of >=18.5 and <25.0
4) Subjects who were identified to have no health problem on physical examination, physical assessment, laboratory tests, or other examinations at screening by the principal investigator or a sub-investigator

Exclude criteria

1) Subjects who are suffering or have a history of any skin disease or skin abnormality at the site of study drug administration (postauricular area) that may prevent evaluation or are receiving treatment at the site of study drug administration that may prevent evaluation (e.g., topical corticosteroids)
2) Subjects who are hypersensitive to scopolamine or atropine (belladonna alkaloid) or have a complication or a history of drug allergy
3) Subjects with a complication or a history of drug abuse (use of an illicit drug) or alcohol dependence
4) Subjects with a history of severe disease that may recur during the study period
5) Subjects with any concurrent illnesses such as angle closure glaucoma, open angle glaucoma, benign prostatic hyperplasia, urinary retention, severe heart disease, congestive heart failure, arrhythmia, paralytic ileus, pyloric stenosis, ileus, ulcerative colitis, asthma, hyperthyroidism, epilepsy, hepatitis, liver dysfunction or kidney dysfunction (however excluding diseases that will not affect study evaluations such as pollinosis without manifestations and verruca)
6) Subjects who received another study drug within 180 days prior to the start of study drug administration
7) Subjects who donated blood of >=400 mL within 12 weeks, blood of >=200 mL within 4 weeks, or blood components within 2 weeks prior to the start of the study
8) Subjects who used any medicinal product (including over the counter drugs except for topical products) or similar product like a dietary supplement (including health food) within 7 days prior to the start of study drug administration
9) Subjects who took any food or beverage containing grapefruit or St. John's wort within 7 days prior to the start of study drug administration
10) Subjects who took any alcohol or caffeine-containing beverage within 3 days prior to the start of study drug administration
11) Subjects who smoked (used a product such as a cigarette, pipe, cigar, chewing tobacco, electronic cigarette, nicotine patch, or nicotine gum) within 90 days prior to the start of study drug administration, or do not agree to stop smoking during the study period
12) Subjects who had a positive result for HBs antigen, HCV antibody, or HIV antigen/antibody, or a positive reaction to syphilis serology or urine drug test at screening
13) Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator based on the 12-lead electrocardiogram at screening (e.g., Fridericia's corrected QT (QTcF) interval of >=450 ms)
14) Subjects who have serum electrolyte levels (potassium, calcium, and magnesium) lower than the institutional reference values
15) Subjects who have a familial history of Torsades de Pointes or long QT syndrome
16) Subjects who had blood pressure, pulse rate, or body temperature at screening as specified below
(1) Systolic blood pressure <90 mmHg or >=140 mmHg
(2) Diastolic blood pressure <40 mmHg or >=90 mmHg
(3) Pulse rate <50 beats/min or >=100 beats/min
(4) Body temperature <35.0 degree or >=37.degree
17) Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator by having a deviation from the institutional reference values
Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator due to other reasons

Related Information

• Primary Sponsor: Miyoshi Katsunori