NCT03423771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

April 18, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

January 30, 2018

Last Update Submit

April 16, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Effective rate of overall intestinal cleaning effect (after washing of the observed region) by the Endoscopic Image Evaluation Committee (EIEC)

    1day

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (7)

NPF-08 Low dose （1-day treatment）

EXPERIMENTAL
Drug: NPF-08

NPF-08 Medium dose （2-day split dose）

EXPERIMENTAL
Drug: NPF-08

NPF-08 High dose （2-day split dose）

EXPERIMENTAL
Drug: NPF-08

NPF-08 Medium dose （1-day treatment）

EXPERIMENTAL
Drug: NPF-08

NPF-08 High dose （1-day treatment）

EXPERIMENTAL
Drug: NPF-08

NPF-08 Low～High dose （1-day treatment）

EXPERIMENTAL
Drug: NPF-08

NPF-08 Medium～High dose （2-day split dose）

EXPERIMENTAL
Drug: NPF-08

Interventions

NPF-08DRUG

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

NPF-08 High dose （1-day treatment）NPF-08 High dose （2-day split dose）NPF-08 Low dose （1-day treatment）NPF-08 Low～High dose （1-day treatment）NPF-08 Medium dose （1-day treatment）NPF-08 Medium dose （2-day split dose）NPF-08 Medium～High dose （2-day split dose）

Eligibility Criteria

Age20 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka

Osaka, Japan

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 6, 2018

Study Start

October 6, 2017

Primary Completion

February 23, 2018

Study Completion

February 28, 2018

Last Updated

April 18, 2018

Record last verified: 2018-02

Locations

JP(1)