A Study of NPC-22 in Healthy Adult Males

A Phase 1 Single Ascending Dose Study of NPC-22 in Healthy Adult Males

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Drug: NPC-22; Drug: NPC-22; Drug: NPC-22 Placebo; Drug: NPC-22; Drug: NPC-22; Drug: NPC-22

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Shinjuku, Tokyo, Japan, 160-0017
      • Medical Corporation Shinanokai Shinanozaka Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Single administration of low dose NPC-22	Drug: NPC-22; Single administration of middle dose NPC-22; Drug: NPC-22; Single administration of high dose NPC-22; Drug: NPC-22; Single administration of low dose NPC-22; Drug: NPC-22; Single administration of low/middle dose NPC-22; Drug: NPC-22; Single administration of middle/high dose NPC-22
Experimental: 2; Single administration of low/middle dose NPC-22	Drug: NPC-22; Single administration of middle dose NPC-22; Drug: NPC-22; Single administration of high dose NPC-22; Drug: NPC-22; Single administration of low dose NPC-22; Drug: NPC-22; Single administration of low/middle dose NPC-22; Drug: NPC-22; Single administration of middle/high dose NPC-22
Experimental: 3; Single administration of middle dose NPC-22	Drug: NPC-22; Single administration of middle dose NPC-22; Drug: NPC-22; Single administration of high dose NPC-22; Drug: NPC-22; Single administration of low dose NPC-22; Drug: NPC-22; Single administration of low/middle dose NPC-22; Drug: NPC-22; Single administration of middle/high dose NPC-22
Experimental: 4; Single administration of middle/high dose NPC-22	Drug: NPC-22; Single administration of middle dose NPC-22; Drug: NPC-22; Single administration of high dose NPC-22; Drug: NPC-22; Single administration of low dose NPC-22; Drug: NPC-22; Single administration of low/middle dose NPC-22; Drug: NPC-22; Single administration of middle/high dose NPC-22
Experimental: 5; Single administration of high dose NPC-22	Drug: NPC-22; Single administration of middle dose NPC-22; Drug: NPC-22; Single administration of high dose NPC-22; Drug: NPC-22; Single administration of low dose NPC-22; Drug: NPC-22; Single administration of low/middle dose NPC-22; Drug: NPC-22; Single administration of middle/high dose NPC-22
Experimental: 6; Single administration of placebo dose NPC-22	Drug: NPC-22 Placebo; Single administration of NPC-22 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	An adverse event will refer to any unfavorable or unintended sign (including an abnormal laboratory finding and abnormality on the 12-lead ECG or in vital signs) and symptom	0-7 days post dose
Body temperature	Body temperature will be measured for assess the safety of single ascending dose of NPC-22	0-7 days post dose
Blood pressure	Blood pressure will be measured for assess the safety of single ascending dose of NPC-22	0-7 days post dose
Pulse rate	Pulse rate will be measured for assess the safety of single ascending dose of NPC-22	0-7 days post dose
ECG	RR, PR, QRS, QT and QTcF interval and heart rate will be measured for assess the safety of single ascending dose of NPC-22	0-7 days post dose
Number and/or rates of subjects with treatment-related adverse events as assessed by hematology tests	Hematology tests will be performed for assessment the safety of single ascending dose of NPC-22	0-7 days post dose
Number and/or rates of subjects with treatment-related adverse events as assessed by blood chemistry tests	Blood chemistry tests will be performed for assessment the safety of single ascending dose of NPC-22	0-7 days post dose
Number and/or rates of subjects with treatment-related adverse events as assessed by urinalysis	Urinalysis will be performed for assessment the safety of single ascending dose of NPC-22	0-7 days post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Observed plasma concentration	0-7 days post dose
Observed urine concentration	0-4 days post dose

Collaborators and Investigators

• Sponsor: Nobelpharma

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): February 4, 2020
• Study Completion (Actual): February 4, 2020

Study Registration Dates

• First Submitted: November 17, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: NPC-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No