An Additional Study of NPC-22 in Healthy Adult Males

Study Overview
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Brief Summary
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The purpose of this study is to examine the safety and pharmacokinetics of high dose NPC-22 administration in healthy adult males. The effect of administration routes for pharmacokinetics will be examined in advance.

Official Title
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Additional Phase 1 Study of NPC-22 for High Dosage in Healthy Adult Males

Conditions
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Safety and Pharmacokinetics

Intervention / Treatment
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* Drug: NPC-22
* Drug: NPC-22
* Drug: NPC-22 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese individuals who have been confirmed to meet all of the following criteria will be enrolled as a subject: Individuals who have provided their own written informed consent Individuals aged ≥20 and <40 years at the time of informed consent Individuals with body weight of ≥50 kg and body mass index (BMI) (kg/m2) of ≥18.5 and <25.0 Individuals 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 Exclusion Criteria: Japanese Individuals who meet any of the following criteria will be excluded from the study: Individuals who are suffering or have a history of any skin disease or skin abnormality at the site of study drug administration (postauricular region, breast, upper arm and abdomen) that may prevent evaluation or are receiving treatment at the site of study drug administration that may prevent evaluation (e.g., topical corticosteroids) Individuals who are hypersensitive to scopolamine or atropine (belladonna alkaloid) or have a complication or a history of drug allergy Individuals with a complication or a history of drug abuse (use of an illicit drug) or alcohol dependence Individuals with a history of severe disease that may recur during the study period Individuals with any concurrent illnesses (including symptoms and findings, however excluding diseases that will not affect study evaluations such as pollinosis without manifestations and verruca) Individuals who received another study drug within 180 days prior to the start of study drug administration Individuals 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 Individuals 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 Individuals who took any food or beverage containing grapefruit or St. John's wort within 7 days prior to the start of study drug administration Individuals who took any alcohol or caffeine-containing beverage within 3 days prior to the start of study drug administration Individuals 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 Individuals 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 Individuals 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] Individuals who have serum electrolyte levels (potassium, calcium, and magnesium) lower than the institutional reference values Individuals who have a familial history of torsades de pointes or long QT syndrome Individuals 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°C or ≥37.1°C Individuals 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 Individuals who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator due to other reasons

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1<br>Single administration of middle dose NPC-22 | Drug: NPC-22<br>* Single administration of middle dose NPC-22<br>|
| Experimental: Experimental 2<br>Single administration of high dose NPC-22 | Drug: NPC-22<br>* Single administration of high dose NPC-22<br>|
| Placebo Comparator: Experimental 3<br>Single administration of placebo dose NPC-22 | Drug: NPC-22 Placebo<br>* Single administration of NPC-22 Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | An adverse event will refer to any unfavorable or unintended sign (including an abnormal laboratory finding and abnormality on the 12-lead ECG or in vital signs) and symptom | 0-14 days post dose | 
| Body temperature | Body temperature will be measured for assess the safety of single ascending dose of NPC-22 | 0-14 days post dose | 
| Blood pressure | Blood pressure will be measured for assess the safety of single ascending dose of NPC-22 | 0-14 days post dose | 
| Pulse rate | Pulse rate will be measured for assess the safety of single ascending dose of NPC-22 | 0-14 days post dose | 
| ECG | RR, PR, QRS, QT and QTcF interval and heart rate will be measured for assess the safety of single ascending dose of NPC-22 | 0-14 days post dose | 
| Number and/or rates of subjects with treatment-related adverse events as assessed by hematology tests | Hematology tests will be performed for assessment the safety of single ascending dose of NPC-22 | 0-14 days post dose | 
| Number and/or rates of subjects with treatment-related adverse events as assessed by blood chemistry tests | Blood chemistry tests will be performed for assessment the safety of single ascending dose of NPC-22 | 0-14 days post dose | 
| Number and/or rates of subjects with treatment-related adverse events as assessed by urinalysis | Urinalysis will be performed for assessment the safety of single ascending dose of NPC-22 | 0-14 days post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed plasma concentration |  | 0-14 days post dose | 
| Observed urine concentration |  | 0-14 days post dose |