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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423771
• Other study ID #: NPF-08-01/SE-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 30, 2018
• Last updated: April 16, 2018
• Start date: October 6, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: February 2018
• Source: Nihon Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 28, 2018
• Est. primary completion date: February 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• NPF-08
Drug: NPF-08 Arms: NPF-08 oral sulfate solution

Locations

Country	Name	City	State
Japan	Osaka	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Nihon Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective rate of overall intestinal cleaning effect (after washing of the observed region) by the Endoscopic Image Evaluation Committee (EIEC)		1day
Secondary	Effective rate of overall intestinal cleaning effect (before washing of observed site) by EIEC		1day
Secondary	Cleaning effect by intestinal site (before/after washing of observed site)		1day
Secondary	Degree of bubbles by intestinal site		1day
Secondary	Time for completion of the bowel cleaning		1day or 2day
Secondary	Total dose of the investigational drug		1day
Secondary	Acceptability by subjects		up to 6hr
Secondary	Coincidence rate of intestinal cleansing degree (before/after washing site of observation) between by EIEC members		1day
Secondary	Coincidence rate between the intestinal cleansing degrees evaluated by EIEC and the endoscope operators (before/after the observed site)		1day