Phase I/II Clinical Trial of NPF-08 in Healthy Volunteers

Study Overview
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Brief Summary
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Japanese male healthy volunteers will receive NPF-08. The efficacy of NPF-08 will be assessed by intestinal cleaning degree. The safety of NPF-08 will be evaluated based on adverse events and adverse drug reactions observed from the date of administration to 7 days after administration.

Official Title
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An Exploratory Phase I/II Study on Safety, Pharmacokinetics and Efficacy of NPF-08 in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: NPF-08


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese healthy male volunteers (20 to 64 years old) BMI（Body Mass Index）should be within a range of 17.6 and 26.4. Subjects who agreed not to smoke or drink during hospital stay. Subjects who do not excessively consume alcohol and those who do not excessively smoke Subjects who are not judged as abnormal during the screening period in the physical examinations including 12-lead ECG, clinical symptoms, clinical examination, immunological examination (hepatitis B examination, hepatitis C examination, AIDS examination, syphilis examination). Subjects who are not judged as abnormal during the before administration in blood electrolyte. Subjects who have no clinical abnormalities and are judged to be eligible to the study by the investigator. Exclusion Criteria: Subjects who had previous significant gastrointestinal surgeries. Subjects with a history of 12-lead ECG abnormality. Subjects who have constipation（less than 2 bowel movement per week） Subjects who have addictive of diarrhea Subjects who have history of shock or hypersensitivity to sulfates (sodium sulfate, potassium sulfate, magnesium sulfate, etc.). Subjects who have history of drug allergy. Subjects who donated 200 mL or 400 mL of whole blood 4 weeks or 12 weeks respectively prior to the administration of investigational drug, or who donated blood component last 2 weeks. Subjects who have participated in an investigational study within 4 months before signing the consent. Subjects who is participating in the other investigational study Subjects who received NPF-08 in the past Subjects who are judged by the investigator as not adequate to participate the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPF-08 Low dose （1-day treatment）<br> | Drug: NPF-08<br>* Drug: NPF-08 Arms: NPF-08 oral sulfate solution<br>|
| Experimental: NPF-08 Medium dose （2-day split dose）<br> | Drug: NPF-08<br>* Drug: NPF-08 Arms: NPF-08 oral sulfate solution<br>|
| Experimental: NPF-08 High dose （2-day split dose）<br> | Drug: NPF-08<br>* Drug: NPF-08 Arms: NPF-08 oral sulfate solution<br>|
| Experimental: NPF-08 Medium dose （1-day treatment）<br> | Drug: NPF-08<br>* Drug: NPF-08 Arms: NPF-08 oral sulfate solution<br>|
| Experimental: NPF-08 High dose （1-day treatment）<br> | Drug: NPF-08<br>* Drug: NPF-08 Arms: NPF-08 oral sulfate solution<br>|
| Experimental: NPF-08 Low～High dose （1-day treatment）<br> | Drug: NPF-08<br>* Drug: NPF-08 Arms: NPF-08 oral sulfate solution<br>|
| Experimental: NPF-08 Medium～High dose （2-day split dose）<br> | Drug: NPF-08<br>* Drug: NPF-08 Arms: NPF-08 oral sulfate solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective rate of overall intestinal cleaning effect (after washing of the observed region) by the Endoscopic Image Evaluation Committee (EIEC) |  | 1day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective rate of overall intestinal cleaning effect (before washing of observed site) by EIEC |  | 1day | 
| Cleaning effect by intestinal site (before/after washing of observed site) |  | 1day | 
| Degree of bubbles by intestinal site |  | 1day | 
| Time for completion of the bowel cleaning |  | 1day or 2day | 
| Total dose of the investigational drug |  | 1day | 
| Acceptability by subjects |  | up to 6hr | 
| Coincidence rate of intestinal cleansing degree (before/after washing site of observation) between by EIEC members |  | 1day | 
| Coincidence rate between the intestinal cleansing degrees evaluated by EIEC and the endoscope operators (before/after the observed site) |  | 1day |