Phase I/II Clinical Trial of NPF-08 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: NPF-08
- Registration Number
- NCT03423771
- Lead Sponsor
- Nihon Pharmaceutical Co., Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NPF-08 Medium dose （2-day split dose） NPF-08 - NPF-08 Low dose （1-day treatment） NPF-08 - NPF-08 High dose （2-day split dose） NPF-08 - NPF-08 Medium dose （1-day treatment） NPF-08 - NPF-08 High dose （1-day treatment） NPF-08 - NPF-08 Low～High dose （1-day treatment） NPF-08 - NPF-08 Medium～High dose （2-day split dose） NPF-08 -
- Primary Outcome Measures
Name Time Method Effective rate of overall intestinal cleaning effect (after washing of the observed region) by the Endoscopic Image Evaluation Committee (EIEC) 1day
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Osaka
🇯🇵Osaka, Japan