Clinical trial NCT03423771: Phase I/II Clinical Trial of NPF-08 in Healthy Volunteers
Official title: An Exploratory Phase I/II Study on Safety, Pharmacokinetics and Efficacy of NPF-08 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteers
Lead sponsor: Nihon Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-02-06
Enrollment: 90
Sex: MALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

1. Japanese healthy male volunteers (20 to 64 years old)
2. BMI（Body Mass Index）should be within a range of 17.6 and 26.4.
3. Subjects who agreed not to smoke or drink during hospital stay.
4. Subjects who do not excessively consume alcohol and those who do not excessively smoke
5. 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).
6. Subjects who are not judged as abnormal during the before administration in blood electrolyte.
7. Subjects who have no clinical abnormalities and are judged to be eligible to the study by the investigator.

Exclusion Criteria:

1. Subjects who had previous significant gastrointestinal surgeries.
2. Subjects with a history of 12-lead ECG abnormality.
3. Subjects who have constipation（less than 2 bowel movement per week）
4. Subjects who have addictive of diarrhea
5. Subjects who have history of shock or hypersensitivity to sulfates (sodium sulfate, potassium sulfate, magnesium sulfate, etc.).
6. Subjects who have history of drug allergy.
7. 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.
8. Subjects who have participated in an investigational study within 4 months before signing the consent.
9. Subjects who is participating in the other investigational study
10. Subjects who received NPF-08 in the past
11. Subjects who are judged by the investigator as not adequate to participate the study.

Primary outcomes:
measure: Effective rate of overall intestinal cleaning effect (after washing of the observed region) by the Endoscopic Image Evaluation Committee (EIEC)
timeFrame: 1day
Secondary outcomes:
measure: Effective rate of overall intestinal cleaning effect (before washing of observed site) by EIEC
timeFrame: 1day
measure: Cleaning effect by intestinal site (before/after washing of observed site)
timeFrame: 1day
measure: Degree of bubbles by intestinal site
timeFrame: 1day
measure: Time for completion of the bowel cleaning
timeFrame: 1day or 2day
measure: Total dose of the investigational drug
timeFrame: 1day
measure: Acceptability by subjects
timeFrame: up to 6hr
measure: Coincidence rate of intestinal cleansing degree (before/after washing site of observation) between by EIEC members
timeFrame: 1day
measure: Coincidence rate between the intestinal cleansing degrees evaluated by EIEC and the endoscope operators (before/after the observed site)
timeFrame: 1day
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka
Study officials:
References: