A Study of NPC-22 in Healthy Adult Males

NCT ID: NCT04203862

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-19
• Study Completion Date: 2020-02-04

Brief Summary

The purpose of this trial is to examine the safety and pharmacokinetics of NPC-22 administered in a single ascending dose in healthy adult males.

Detailed Description

The healthy adult males will be randomized into six arms, and will receive single dose of NPC-22 (five doses, placebo)

Conditions

Healthy Adult Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

1

Single administration of low dose NPC-22

Group Type: EXPERIMENTAL

NPC-22

Intervention Type: DRUG

Single administration of low dose NPC-22

2

Single administration of low/middle dose NPC-22

Group Type: EXPERIMENTAL

NPC-22

Intervention Type: DRUG

Single administration of low/middle dose NPC-22

3

Single administration of middle dose NPC-22

Group Type: EXPERIMENTAL

NPC-22

Intervention Type: DRUG

Single administration of middle dose NPC-22

4

Single administration of middle/high dose NPC-22

Group Type: EXPERIMENTAL

NPC-22

Intervention Type: DRUG

Single administration of middle/high dose NPC-22

5

Single administration of high dose NPC-22

Group Type: EXPERIMENTAL

NPC-22

Intervention Type: DRUG

Single administration of high dose NPC-22

6

Single administration of placebo dose NPC-22

Group Type: EXPERIMENTAL

NPC-22 Placebo

Intervention Type: DRUG

Single administration of NPC-22 Placebo

Interventions

NPC-22

Single administration of low dose NPC-22

Intervention Type: DRUG

NPC-22

Single administration of low/middle dose NPC-22

Intervention Type: DRUG

NPC-22

Single administration of middle dose NPC-22

Intervention Type: DRUG

NPC-22

Single administration of middle/high dose NPC-22

Intervention Type: DRUG

NPC-22

Single administration of high dose NPC-22

Intervention Type: DRUG

NPC-22 Placebo

Single administration of NPC-22 Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects who have provided their own written informed consent

2. Subjects aged ≥20 and <40 years at the time of informed consent

3. Subjects with body weight of ≥50 kg and body mass index (BMI) (kg/m2) of ≥18.5 and <25.0

4. Subjects who were identified to have no health problem on physical examination, physical assessment, laboratory tests, or other examinations at screening by the principal investigator or a sub-investigator

Exclusion Criteria

1. Subjects with a complication or a history of drug abuse (use of an illicit drug) or alcohol dependence

2. Subjects with a history of severe disease that may recur during the study period

3. Subjects with any concurrent illnesses

4. Subjects who received another study drug within 180 days prior to the start of study drug administration

5. Subjects who donated blood of ≥400 mL within 12 weeks, blood of ≥200 mL within 4 weeks, or blood components within 2 weeks prior to the start of the study

6. Subjects who used any medicinal product (including over the counter drugs except for topical products) or similar product like a dietary supplement (including health food) within 7 days prior to the start of study drug administration

7. Subjects who took any food or beverage containing grapefruit or St. John's wort within 7 days prior to the start of study drug administration

8. Subjects who took any alcohol or caffeine-containing beverage within 3 days prior to the start of study drug administration

9. Subjects who smoked within 90 days prior to the start of study drug administration, or do not agree to stop smoking during the study period

10. Subjects who had a positive result for HBs antigen, HCV antibody, or HIV antigen/antibody, or a positive reaction to syphilis serology or urine drug test at screening

11. Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator based on the 12-lead electrocardiogram at screening [e.g., Fridericia's corrected QT (QTcF) interval of ≥450 ms]

12. Subjects who have a familial history of torsades de pointes or long QT syndrome

13. Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator by having a deviation from the institutional reference values

14. Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator due to other reasons

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nobelpharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Corporation Shinanokai Shinanozaka Clinic

Shinjuku, Tokyo, Japan

Countries

Japan

Other Identifiers

NPC-22

Identifier Type: -

Identifier Source: org_study_id