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

Nihon Pharmaceutical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: NPF-08

Study type: Interventional

Funder types: Industry

Identifiers

NCT03423771

NPF-08-01/SE-01

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Male

Ages: 20 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 7 patient groups

NPF-08 Low dose （1-day treatment）

Experimental group

Treatment:

Drug: NPF-08

NPF-08 Medium dose （2-day split dose）

Experimental group

Treatment:

Drug: NPF-08

NPF-08 High dose （2-day split dose）

Experimental group

Treatment:

Drug: NPF-08

NPF-08 Medium dose （1-day treatment）

Experimental group

Treatment:

Drug: NPF-08

NPF-08 High dose （1-day treatment）

Experimental group

Treatment:

Drug: NPF-08

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

Experimental group

Treatment:

Drug: NPF-08

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

Experimental group

Treatment:

Drug: NPF-08