Qt Interval, Variation inPhase 1NCT03475459
Investigation of Arrhythmogenic Effect of NPC-15 (NPC-15-7)
A Phase 1 study of Qt Interval, Variation in, run by Nobelpharma at 1 site in Japan.
Trial summary
A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg) Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Qt Interval, Variation in
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- 3 Apr 2018to 29 Apr 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject with BMI ≥ 17.6 kg/m2 and < 30.0 kg/m2.
- Subject who falls asleep at between 21:00 and 25:00 and wakes up at between 5:00 and 9:00 during 1 week prior to the first study drug administration.
- Subject who is able to comply with the study requirements during the study period.
Who cannot join
- Subject with QTcF interval greater than 450 ms in male or greater than 470 ms in female on the 12-lead electrocardiogram (ECG), or with clinically significant ECG abnormalities in other findings.
- Subject who has a family history of Torsades de Pointes (TdP) or long QT syndrome.
- Subject who has a history of hypersensitivity or allergies to melatonin or ramelteon.
- Subject who has a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments.
- Subject who received any non-prescription or prescription drug within 2 weeks prior to the first study drug administration.
- Subject who received any product containing St Jones Wart or any supplement containing melatonin within 4 weeks prior to the first study drug administration.
- Subject who has a history of smoking habit or was possibly exposed to passive smoking on a daily basis within 24 weeks prior to the first study drug administration.
- Subject who, in the opinion of the investigator or sub-investigator, is unsuitable to be involved in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Pharmacology Study of NPC-15 to Evaluate Arrhythmogenic Effect in Healthy Adults
A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)
Read the detailed description
This study is a single center, open label, dose escalation trial to evaluate prolongation effect on QT interval of NPC-15 (melatonin 8mg or 16mg).
The trial compose of 3 periods; During the each period, eligible volunteers wll be administered placebo, NPC-15 4g (melatonin 8mg) and NPC-15 8g(melatonin 16mg) as a sequential manner.
- Conditions
- Qt Interval, Variation in
- Being tested
- NPC-15 and/or Placebo
- Keywords
- QTc prolongation effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPC-15 and/or PlaceboDrug
Also called Melatonin and/or Placebo
The dosage and regimen of the study drug in each period is the following. Period I : NPC-15 placebo granules 8 g Period II : NPC-15 placebo granules 4 g + NPC-15 granules 0.2% 4 g (melatonin 8 mg) Period III : NPC-15 granules 0.2% 8 g (melatonin 16 mg)
| Study group | Role | What they receive |
|---|---|---|
| study drug | Experimental | Study drug (NPC-15 and/or Placebo ) will be orally administered once with 200 ml of water at 20:00 on the first days of Period I, Period II and Period III. Receives: Drug: NPC-15 and/or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time matched, baseline-adjusted change in Fridericia-corrected QTc (QTcF) intervals
QTcF interval is a common endpoints to evaluate arrhythmogenic effect of test drug
Measured: Day1 and Day2 of each periods (3 periods)
Secondary outcomes (10)
Serum melatonin concentration
NPC-15 is a preparation containing melatonin , therefore the change in blood concentration of melatonin is useful to evaluate the QTc prolongation effect of NPC-15.
Measured: Up to 12 hours post dose in each period (3 periods)
Maximum drug concentration (Cmax) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Measured: Up to 12 hours post dose in each period (3 periods)
Maximum drug concentration time (Tmax) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Measured: Up to 12 hours post dose in each period (3 periods)
Area under the blood concentration time curve (AUC) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Measured: Up to 12 hours postdose in each period (3 periods)
Terminal elimination rate constant (λz) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Measured: Up to 12 hours post dose in each period (3 periods)
Mean residence time (MRT) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Measured: Up to 12 hours postdose in each period (3 periods)
Elimination half-life (t1/2) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Measured: Up to 12 hours post dose in each period
Clearance (CL) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Measured: Up to 12 hours post dose in each period (3 periods)
Volume of distribution (Vd) of melatonin
NPC-15 is a preparation containing melatonin , therefore pharmacokinetic parameter is useful to evaluate the QTc prolongation effect of NPC-15.
Measured: Up to 12 hours postdose in each period (3 periods)
Adverse Events
All events that emerge during treatment, having been absent pretreatment, or worsens relative to the pretreatment state
Measured: Up to 36 hours post dose of Period III
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start3 Apr 2018
- Primary completion29 Apr 2018
- Study completion29 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Qt Interval, Variation inStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masaharu Hayashi, MD, PhD, Principal investigator, Shukutoku University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475459
- Sponsor's protocol ID
- NPC-15-7
- Status last verified
- Apr 2018
- First submitted
- 22 Feb 2018
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacology Study of NPC-15 to Evaluate Arrhythmogenic Effect in Healthy Adults
- ClinicalTrials.gov ID
- NCT03475459
- Acronym / sponsor ID
- NPC-15-7
- Conditions
- Qt Interval, Variation in
- Keywords
- QTc prolongation effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 29 Apr 2018 (actual)
- Study completion
- 29 Apr 2018 (actual)
- First posted
- 23 Mar 2018 (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.
A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)
Detailed description
This study is a single center, open label, dose escalation trial to evaluate prolongation effect on QT interval of NPC-15 (melatonin 8mg or 16mg).
The trial compose of 3 periods; During the each period, eligible volunteers wll be administered placebo, NPC-15 4g (melatonin 8mg) and NPC-15 8g(melatonin 16mg) as a sequential manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study drug | Experimental | Drug: NPC-15 and/or PlaceboStudy drug (NPC-15 and/or Placebo ) will be orally administered once with 200 ml of water at 20:00 on the first days of Period I, Period II and Period III. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject with BMI ≥ 17.6 kg/m2 and < 30.0 kg/m2.
- Subject who falls asleep at between 21:00 and 25:00 and wakes up at between 5:00 and 9:00 during 1 week prior to the first study drug administration.
- Subject who is able to comply with the study requirements during the study period.
Key exclusion criteria (8 listed)
- Subject with QTcF interval greater than 450 ms in male or greater than 470 ms in female on the 12-lead electrocardiogram (ECG), or with clinically significant ECG abnormalities in other findings.
- Subject who has a family history of Torsades de Pointes (TdP) or long QT syndrome.
- Subject who has a history of hypersensitivity or allergies to melatonin or ramelteon.
- Subject who has a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments.
- Subject who received any non-prescription or prescription drug within 2 weeks prior to the first study drug administration.
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-15 and/or PlaceboAlso: Melatonin and/or PlaceboThe dosage and regimen of the study drug in each period is the following. Period I : NPC-15 placebo granules 8 g Period II : NPC-15 placebo granules 4 g + NPC-15 granules 0.2% 4 g (melatonin 8 mg) Period III : NPC-15 granules 0.2% 8 g (melatonin 16 mg) | Drug | study drug |
Primary outcome
Time matched, baseline-adjusted change in Fridericia-corrected QTc (QTcF) intervals
Time frame: Day1 and Day2 of each periods (3 periods)
QTcF interval is a common endpoints to evaluate arrhythmogenic effect of test drug
10 secondary outcomes
Serum melatonin concentration
Time frame: Up to 12 hours post dose in each period (3 periods)
Maximum drug concentration (Cmax) of melatonin
Time frame: Up to 12 hours post dose in each period (3 periods)
Maximum drug concentration time (Tmax) of melatonin
Time frame: Up to 12 hours post dose in each period (3 periods)
Area under the blood concentration time curve (AUC) of melatonin
Time frame: Up to 12 hours postdose in each period (3 periods)
Terminal elimination rate constant (λz) of melatonin
Time frame: Up to 12 hours post dose in each period (3 periods)
Mean residence time (MRT) of melatonin
Time frame: Up to 12 hours postdose in each period (3 periods)
Elimination half-life (t1/2) of melatonin
Time frame: Up to 12 hours post dose in each period
Clearance (CL) of melatonin
Time frame: Up to 12 hours post dose in each period (3 periods)
Volume of distribution (Vd) of melatonin
Time frame: Up to 12 hours postdose in each period (3 periods)
Adverse Events
Time frame: Up to 36 hours post dose of Period III
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 28 Jun 2018.
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.
Masaharu Hayashi, MD, PhD principal investigator
Shukutoku University
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 of Qt Interval, Variation in, 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 3 inclusion and 8 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 28 Jun 2018. 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. 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?
Time matched, baseline-adjusted change in Fridericia-corrected QTc (QTcF) intervals (time frame: Day1 and Day2 of each periods (3 periods)). 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 28 Jun 2018.