A Study of NPC-22 in Healthy Adult Males

August 5, 2020 updated by: Nobelpharma

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 0-7 days post dose
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
Time Frame: 0-7 days post dose
Body temperature will be measured for assess the safety of single ascending dose of NPC-22
0-7 days post dose
Blood pressure
Time Frame: 0-7 days post dose
Blood pressure will be measured for assess the safety of single ascending dose of NPC-22
0-7 days post dose
Pulse rate
Time Frame: 0-7 days post dose
Pulse rate will be measured for assess the safety of single ascending dose of NPC-22
0-7 days post dose
ECG
Time Frame: 0-7 days post dose
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
Time Frame: 0-7 days post dose
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
Time Frame: 0-7 days post dose
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
Time Frame: 0-7 days post dose
Urinalysis will be performed for assessment the safety of single ascending dose of NPC-22
0-7 days post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Observed plasma concentration
Time Frame: 0-7 days post dose
0-7 days post dose
Observed urine concentration
Time Frame: 0-4 days post dose
0-4 days post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nobelpharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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