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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: NPF-08

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Osaka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nihon Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2017
• Primary Completion (Actual): February 23, 2018
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NPF-08-01/SE-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No