- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04503863
An Additional Study of NPC-22 in Healthy Adult Males
Additional Phase 1 Study of NPC-22 for High Dosage in Healthy Adult Males
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Tokyo
-
Shinjuku-Ku, Tokyo, Japan, 160-0017
- Medical Corporation Shinanokai Shinanozaka Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental 1
Single administration of middle dose NPC-22
|
Single administration of middle dose NPC-22
Single administration of high dose NPC-22
|
Experimental: Experimental 2
Single administration of high dose NPC-22
|
Single administration of middle dose NPC-22
Single administration of high dose NPC-22
|
Placebo Comparator: Experimental 3
Single administration of placebo dose NPC-22
|
Single administration of NPC-22 Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 0-14 days post dose
|
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
Time Frame: 0-14 days post dose
|
Body temperature will be measured for assess the safety of single ascending dose of NPC-22
|
0-14 days post dose
|
Blood pressure
Time Frame: 0-14 days post dose
|
Blood pressure will be measured for assess the safety of single ascending dose of NPC-22
|
0-14 days post dose
|
Pulse rate
Time Frame: 0-14 days post dose
|
Pulse rate will be measured for assess the safety of single ascending dose of NPC-22
|
0-14 days post dose
|
ECG
Time Frame: 0-14 days post dose
|
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
Time Frame: 0-14 days post dose
|
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
Time Frame: 0-14 days post dose
|
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
Time Frame: 0-14 days post dose
|
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 |
Time Frame |
---|---|
Observed plasma concentration
Time Frame: 0-14 days post dose
|
0-14 days post dose
|
Observed urine concentration
Time Frame: 0-14 days post dose
|
0-14 days post dose
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NPC-22-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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