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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03423771
• Date of registration: 30/01/2018
• Prospective Registration: No
• Primary sponsor: Nihon Pharmaceutical Co., Ltd
• Public title: Phase I/II Clinical Trial of NPF-08 in Healthy Volunteers
• Scientific title: An Exploratory Phase I/II Study on Safety, Pharmacokinetics and Efficacy of NPF-08 in Healthy Volunteers
• Date of first enrolment: October 6, 2017
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03423771
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Japan

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 64 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: NPF-08

Primary Outcome(s)

Effective rate of overall intestinal cleaning effect (after washing of the observed region) by the Endoscopic Image Evaluation Committee (EIEC) [Time Frame: 1day]

Secondary Outcome(s)

Coincidence rate of intestinal cleansing degree (before/after washing site of observation) between by EIEC members [Time Frame: 1day]

Cleaning effect by intestinal site (before/after washing of observed site) [Time Frame: 1day]

Coincidence rate between the intestinal cleansing degrees evaluated by EIEC and the endoscope operators (before/after the observed site) [Time Frame: 1day]

Time for completion of the bowel cleaning [Time Frame: 1day or 2day]

Degree of bubbles by intestinal site [Time Frame: 1day]

Acceptability by subjects [Time Frame: up to 6hr]

Effective rate of overall intestinal cleaning effect (before washing of observed site) by EIEC [Time Frame: 1day]

Total dose of the investigational drug [Time Frame: 1day]

Secondary ID(s)

NPF-08-01/SE-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors