An Additional Study of NPC-22 in Healthy Adult Males

NCT04503863 | Completed Phase 1

• 1 other identifier: NPC-22-2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Safety and Pharmacokinetics

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

  0-14 days post dose

• Body temperature

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

  0-14 days post dose

• Blood pressure

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

  0-14 days post dose

• Pulse rate

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

  0-14 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

  0-14 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

  0-14 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

  0-14 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

  0-14 days post dose

Secondary Outcomes (2)

• Observed plasma concentration

  0-14 days post dose

• Observed urine concentration

  0-14 days post dose

Study Arms (3)

Experimental 1

EXPERIMENTAL

Single administration of middle dose NPC-22

Drug: NPC-22

Experimental 2

EXPERIMENTAL

Single administration of high dose NPC-22

Drug: NPC-22

Experimental 3

PLACEBO COMPARATOR

Single administration of placebo dose NPC-22

Drug: NPC-22 Placebo

Interventions

NPC-22 DRUG

Single administration of middle dose NPC-22

Experimental 1

NPC-22 Placebo DRUG

Single administration of NPC-22 Placebo

Experimental 3

Eligibility Criteria

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

You may qualify if:

• Japanese individuals who have been confirmed to meet all of the following criteria will be enrolled as a subject:
• Individuals who have provided their own written informed consent
• Individuals aged ≥20 and \<40 years at the time of informed consent
• Individuals with body weight of ≥50 kg and body mass index (BMI) (kg/m2) of ≥18.5 and \<25.0
• 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

You may not qualify if:

• Japanese Individuals who meet any of the following criteria will be excluded from the study:
• 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)
• Individuals who are hypersensitive to scopolamine or atropine (belladonna alkaloid) or have a complication or a history of drug allergy
• Individuals with a complication or a history of drug abuse (use of an illicit drug) or alcohol dependence
• Individuals with a history of severe disease that may recur during the study period
• 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)
• Individuals who received another study drug within 180 days prior to the start of study drug administration
• 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
• 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
• 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
• Individuals who took any alcohol or caffeine-containing beverage within 3 days prior to the start of study drug administration
• 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
• 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
• 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 \[e.g., Fridericia's corrected QT (QTcF) interval of ≥450 ms\]
• Individuals who have serum electrolyte levels (potassium, calcium, and magnesium) lower than the institutional reference values

Sponsors & Collaborators

• Nobelpharma: lead

Study Sites (1)

Medical Corporation Shinanokai Shinanozaka Clinic

Shinjuku-Ku, 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: August 5, 2020
• First Posted: August 7, 2020
• Study Start: July 20, 2020
• Primary Completion: November 6, 2020
• Study Completion: December 28, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-02

Locations

JP (1)