Safety and PharmacokineticsPhase 1NCT04503863
An Additional Study of NPC-22 in Healthy Adult Males
A Phase 1 study testing NPC-22 in people with Safety and Pharmacokinetics, run by Nobelpharma at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Safety and Pharmacokinetics
- What is being tested?
- NPC-22
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 20 Jul 2020to 28 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
- Individuals who have a familial history of torsades de pointes or long QT syndrome
- 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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Medical Corporation Shinanokai Shinanozaka Clinic
Shinjuku-Ku, Tokyo, 160-0017
About this study
Official title: Additional Phase 1 Study of NPC-22 for High Dosage in Healthy Adult Males
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
- Being tested
- NPC-22, NPC-22 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPC-22Drug
Single administration of middle dose NPC-22
NPC-22Drug
Single administration of high dose NPC-22
NPC-22 PlaceboDrug
Single administration of NPC-22 Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Single administration of middle dose NPC-22 Receives: Drug: NPC-22 |
| Experimental 2 | Experimental | Single administration of high dose NPC-22 Receives: Drug: NPC-22 |
| Experimental 3 | Placebo comparator | Single administration of placebo dose NPC-22 Receives: Drug: NPC-22 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-14 days post dose
Body temperature
Body temperature will be measured for assess the safety of single ascending dose of NPC-22
Measured: 0-14 days post dose
Blood pressure
Blood pressure will be measured for assess the safety of single ascending dose of NPC-22
Measured: 0-14 days post dose
Pulse rate
Pulse rate will be measured for assess the safety of single ascending dose of NPC-22
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0-14 days post dose
Secondary outcomes (2)
Observed plasma concentration
Measured: 0-14 days post dose
Observed urine concentration
Measured: 0-14 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start20 Jul 2020
- Primary completion6 Nov 2020
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503863
- Sponsor's protocol ID
- NPC-22-2
- Status last verified
- Feb 2022
- First submitted
- 5 Aug 2020
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Phase 1 Study of NPC-22 for High Dosage in Healthy Adult Males
- ClinicalTrials.gov ID
- NCT04503863
- Acronym / sponsor ID
- NPC-22-2
- Conditions
- Safety and Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: NPC-22Single administration of middle dose NPC-22 |
| Experimental 2 | Experimental | Drug: NPC-22Single administration of high dose NPC-22 |
| Experimental 3 | Placebo comparator | Drug: NPC-22 PlaceboSingle administration of placebo dose NPC-22 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPC-22Single administration of middle dose NPC-22 | Drug | Experimental 1 |
| NPC-22Single administration of high dose NPC-22 | Drug | Experimental 2 |
| NPC-22 PlaceboSingle administration of NPC-22 Placebo | Drug | Experimental 3 |
Primary outcome
Adverse events
Time frame: 0-14 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
Body temperature
Time frame: 0-14 days post dose
Body temperature will be measured for assess the safety of single ascending dose of NPC-22
Blood pressure
Time frame: 0-14 days post dose
Blood pressure will be measured for assess the safety of single ascending dose of NPC-22
Pulse rate
Time frame: 0-14 days post dose
Pulse rate will be measured for assess the safety of single ascending dose of NPC-22
ECG
Time frame: 0-14 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
Number and/or rates of subjects with treatment-related adverse events as assessed by hematology tests
Time frame: 0-14 days post dose
Hematology tests will be performed for assessment the safety of single ascending dose of NPC-22
Number and/or rates of subjects with treatment-related adverse events as assessed by blood chemistry tests
Time frame: 0-14 days post dose
Blood chemistry tests will be performed for assessment the safety of single ascending dose of NPC-22
Number and/or rates of subjects with treatment-related adverse events as assessed by urinalysis
Time frame: 0-14 days post dose
Urinalysis will be performed for assessment the safety of single ascending dose of NPC-22
2 secondary outcomes
Observed plasma concentration
Time frame: 0-14 days post dose
Observed urine concentration
Time frame: 0-14 days post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NPC-22 in people with Safety and Pharmacokinetics, run by Nobelpharma at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 0-14 days post dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.