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CompletedNCT04503863Updated Feb 7, 2022

An Additional Study of NPC-22 in Healthy Adult Males

A Phase 1 interventional study of NPC-22 and NPC-22 in Safety and Pharmacokinetics, sponsored by Nobelpharma. Completed at 1 site in Japan. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-07.

Sponsored by Nobelpharma · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study summary

The purpose of this study is to examine the safety and pharmacokinetics of high dose NPC-22 administration in healthy adult males.

The effect of administration routes for pharmacokinetics will be examined in advance.

02

Conditions studied

  • Safety and Pharmacokinetics
03

In context

Lead sponsor

Nobelpharma is the lead sponsor of 34 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

Japanese individuals who have been confirmed to meet all of the following criteria will be enrolled as a subject:

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

Exclusion Criteria:

Japanese Individuals who meet any of the following criteria will be excluded from the study:

  1. Individuals who are suffering or have a history of any skin disease or skin abnormality at the site of study drug administration (postauricular region, breast, upper arm and abdomen) that may prevent evaluation or are receiving treatment at the site of study drug administration that may prevent evaluation (e.g., topical corticosteroids)
  2. Individuals who are hypersensitive to scopolamine or atropine (belladonna alkaloid) or have a complication or a history of drug allergy
  3. Individuals with a complication or a history of drug abuse (use of an illicit drug) or alcohol dependence
  4. Individuals with a history of severe disease that may recur during the study period
  5. Individuals with any concurrent illnesses (including symptoms and findings, however excluding diseases that will not affect study evaluations such as pollinosis without manifestations and verruca)
  6. Individuals who received another study drug within 180 days prior to the start of study drug administration
  7. Individuals 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
  8. Individuals 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
  9. Individuals who took any food or beverage containing grapefruit or St. John's wort within 7 days prior to the start of study drug administration
  10. Individuals who took any alcohol or caffeine-containing beverage within 3 days prior to the start of study drug administration
  11. Individuals who smoked (used a product such as a cigarette, pipe, cigar, chewing tobacco, electronic cigarette, nicotine patch, or nicotine gum) within 90 days prior to the start of study drug administration, or do not agree to stop smoking during the study period
  12. Individuals 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
  13. Individuals 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]
  14. Individuals who have serum electrolyte levels (potassium, calcium, and magnesium) lower than the institutional reference values
  15. Individuals who have a familial history of torsades de pointes or long QT syndrome
  16. Individuals who had blood pressure, pulse rate, or body temperature at screening as specified below [1]Systolic blood pressure: \<90 mmHg or ≥140 mmHg [2]Diastolic blood pressure: \<40 mmHg or ≥90 mmHg [3]Pulse rate: \<50 beats/min or ≥100 beats/min [4]Body temperature: \<35.0°C or ≥37.1°C
  17. Individuals 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
  18. Individuals who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator due to other reasons
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Experimental 1

    Single administration of middle dose NPC-22

    Drug: NPC-22

  • Experimental
    Experimental 2

    Single administration of high dose NPC-22

    Drug: NPC-22

  • Placebo comparator
    Experimental 3

    Single administration of placebo dose NPC-22

    Drug: NPC-22 Placebo

Interventions

  • DrugNPC-22

    Single administration of middle dose NPC-22

  • DrugNPC-22

    Single administration of high dose NPC-22

  • DrugNPC-22 Placebo

    Single administration of NPC-22 Placebo

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 0-14 days post dose

  2. Body temperature

    Body temperature will be measured for assess the safety of single ascending dose of NPC-22

    Time frame: 0-14 days post dose

  3. Blood pressure

    Blood pressure will be measured for assess the safety of single ascending dose of NPC-22

    Time frame: 0-14 days post dose

  4. Pulse rate

    Pulse rate will be measured for assess the safety of single ascending dose of NPC-22

    Time frame: 0-14 days post dose

  5. 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

    Time frame: 0-14 days post dose

  6. 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

    Time frame: 0-14 days post dose

  7. 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

    Time frame: 0-14 days post dose

  8. 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

    Time frame: 0-14 days post dose

Secondary outcomes

  1. Observed plasma concentration

    Time frame: 0-14 days post dose

  2. Observed urine concentration

    Time frame: 0-14 days post dose

07

Study locations

1 site
  • Medical Corporation Shinanokai Shinanozaka Clinic
    Shinjuku-Ku, Tokyo 160-0017, Japan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04503863
Lead sponsor
Nobelpharma
Responsible party
Sponsor
First posted
Aug 7, 2020
Start date
Jul 20, 2020
Primary completion
Nov 6, 2020
Completion
Dec 28, 2021
Last update
Feb 7, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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