A Study of NPC-22 in Healthy Adult Males

NCT04203862 | Completed Phase 1

• 1 other identifier: NPC-22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Observed plasma concentration

  0-7 days post dose

• Observed urine concentration

  0-4 days post dose

Study Arms (6)

1

EXPERIMENTAL

Single administration of low dose NPC-22

Drug: NPC-22

2

EXPERIMENTAL

Single administration of low/middle dose NPC-22

Drug: NPC-22

3

EXPERIMENTAL

Single administration of middle dose NPC-22

Drug: NPC-22

4

EXPERIMENTAL

Single administration of middle/high dose NPC-22

Drug: NPC-22

5

EXPERIMENTAL

Single administration of high dose NPC-22

Drug: NPC-22

6

EXPERIMENTAL

Single administration of placebo dose NPC-22

Drug: NPC-22 Placebo

Interventions

NPC-22 DRUG

Single administration of low dose NPC-22

1

NPC-22 Placebo DRUG

Single administration of NPC-22 Placebo

6

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who have provided their own written informed consent
• Subjects aged ≥20 and \<40 years at the time of informed consent
• Subjects with body weight of ≥50 kg and body mass index (BMI) (kg/m2) of ≥18.5 and \<25.0
• 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

You may not qualify if:

• Subjects with a complication or a history of drug abuse (use of an illicit drug) or alcohol dependence
• Subjects with a history of severe disease that may recur during the study period
• Subjects with any concurrent illnesses
• Subjects who received another study drug within 180 days prior to the start of study drug administration
• 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
• 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
• 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
• Subjects who took any alcohol or caffeine-containing beverage within 3 days prior to the start of study drug administration
• 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
• 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
• 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 \[e.g., Fridericia's corrected QT (QTcF) interval of ≥450 ms\]
• Subjects who have a familial history of torsades de pointes or long QT syndrome
• 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
• 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

Sponsors & Collaborators

• Nobelpharma: lead

Study Sites (1)

Medical Corporation Shinanokai Shinanozaka Clinic

Shinjuku, Tokyo, 160-0017, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: December 18, 2019
• Study Start: November 19, 2019
• Primary Completion: February 4, 2020
• Study Completion: February 4, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

JP (1)