DyslipidemiasPhase 1NCT03577275
A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval
A Phase 1 study testing NST-4016 600mg, Moxifloxacin 400mg and NST-4016 2000mg in people with Dyslipidemias, run by NorthSea Therapeutics B.V. at 1 site in United Kingdom.
Trial summary
This is a Phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo and positive controlled, 4 way crossover study assessing the ECG effects of therapeutic and supratherapeutic doses of icosabutate in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- NST-4016 600mg, Moxifloxacin 400mg and NST-4016 2000mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2018to 24 Sep 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
- 2. Body mass index (BMI) between 18.0 and 33.0 kg/m2, inclusive, at Screening
- 3. In good health
Who cannot join
- 1. An uninterpretable or abnormal ECG at Screening and/or Check in
- 2. History of risk factors for Torsades de Pointes
- 3. sustained supine systolic blood pressure >140 mmHg or <90 mmHg
- 4. Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
- 5. Female subjects who are pregnant (or planning to become pregnant within 90 days after the final dose administration) or are currently lactating
- 6. Subjects who, in the opinion of the Investigator (or designee), should not participate in this study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit (CRU) Ltd
Leeds, LS2 9LH
About this study
Official title: A Randomised, Partially Double Blind, Placebo and Positive Controlled, 4 Way Crossover Study to Evaluate the Effect of Icosabutate (NST 4016) on the QT/QTc Interval in Healthy Subjects
This is a Phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo and positive controlled, 4 way crossover study assessing the ECG effects of therapeutic and supratherapeutic doses of icosabutate in healthy male and female subjects.
- Conditions
- Dyslipidemias
- Being tested
- NST-4016 600mg, Placebo oral capsule, Moxifloxacin 400mg, NST-4016 2000mg
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NST-4016 600mgDrug
Also called Icosabutate
Likely maximum therapeutic dose of NST-4016
Placebo oral capsuleDrug
Placebo for comparison with moxifloxacin and potential NST-4016 effects
Moxifloxacin 400mgDrug
Active comparator with known effect on QT interval
NST-4016 2000mgDrug
Also called Icosabutate
Supratherapeutic dose of NST-4016
| Study group | Role | What they receive |
|---|---|---|
| Placebo oral capsule | Placebo comparator | Single dose of placebo to match NST-4016 Receives: Drug: Placebo oral capsule |
| Moxifloxacin 400mg | Active comparator | Single 400mg dose of active comparator moxifloxacin (open label) Receives: Drug: Moxifloxacin 400mg |
| NST-4016 600mg | Experimental | Likely therapeutic dose of NST-4016 Receives: Drug: NST-4016 600mg |
| NST-4016 2000mg | Experimental | Supratherapeutic dose of NST-4016 Receives: Drug: NST-4016 2000mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Fridericia's Correction for QT Interval (QTcF)
Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)
Measured: 24 hours
Secondary outcomes (4)
Change From Baseline in Heart Rate (HR)
Electrocardiogram measurement of change from baseline in heart rate (HR) maximum values presented
Measured: 24 hours
Change From Baseline in Fridericia's Correction for QT Interval (QTcF)
Electrocardiogram measurement of change from baseline in Fridericia's correction for QT interval (QTcF)
Measured: 24 hours
Change From Baseline in PR Interval (PR)
Electrocardiogram measurement of change from baseline in PR interval (PR)
Measured: 24 hours
Change From Baseline in QRS Interval (QRS)
Electrocardiogram measurement of change from baseline in QRS interval (QRS)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start15 Jun 2018
- Primary completion15 Sep 2018
- Study completion24 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyslipidemiasStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- NorthSea Therapeutics B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577275
- Sponsor's protocol ID
- NST-01
- Status last verified
- Oct 2019
- First submitted
- 22 Jun 2018
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Partially Double Blind, Placebo and Positive Controlled, 4 Way Crossover Study to Evaluate the Effect of Icosabutate (NST 4016) on the QT/QTc Interval in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03577275
- Acronym / sponsor ID
- NST-01
- Conditions
- Dyslipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NorthSea Therapeutics B.V.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo and positive controlled, 4 way crossover study assessing the ECG effects of therapeutic and supratherapeutic doses of icosabutate in healthy male and female subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsuleSingle dose of placebo to match NST-4016 |
| Moxifloxacin 400mg | Active comparator | Drug: Moxifloxacin 400mgSingle 400mg dose of active comparator moxifloxacin (open label) |
| NST-4016 600mg | Experimental | Drug: NST-4016 600mgLikely therapeutic dose of NST-4016 |
| NST-4016 2000mg | Experimental | Drug: NST-4016 2000mgSupratherapeutic dose of NST-4016 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
- 2. Body mass index (BMI) between 18.0 and 33.0 kg/m2, inclusive, at Screening
- 3. In good health
Key exclusion criteria (6 listed)
- 1. An uninterpretable or abnormal ECG at Screening and/or Check in
- 2. History of risk factors for Torsades de Pointes
- 3. sustained supine systolic blood pressure >140 mmHg or <90 mmHg
- 4. Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
- 5. Female subjects who are pregnant (or planning to become pregnant within 90 days after the final dose administration) or are currently lactating
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 |
|---|---|---|
| NST-4016 600mgAlso: IcosabutateLikely maximum therapeutic dose of NST-4016 | Drug | NST-4016 600mg |
| Placebo oral capsulePlacebo for comparison with moxifloxacin and potential NST-4016 effects | Drug | Placebo oral capsule |
| Moxifloxacin 400mgActive comparator with known effect on QT interval | Drug | Moxifloxacin 400mg |
| NST-4016 2000mgAlso: IcosabutateSupratherapeutic dose of NST-4016 | Drug | NST-4016 2000mg |
Primary outcome
Change From Baseline in Fridericia's Correction for QT Interval (QTcF)
Time frame: 24 hours
Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)
4 secondary outcomes
Change From Baseline in Heart Rate (HR)
Time frame: 24 hours
Change From Baseline in Fridericia's Correction for QT Interval (QTcF)
Time frame: 24 hours
Change From Baseline in PR Interval (PR)
Time frame: 24 hours
Change From Baseline in QRS Interval (QRS)
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 NST-4016 600mg, Moxifloxacin 400mg and NST-4016 2000mg in people with Dyslipidemias, run by NorthSea Therapeutics B.V. at 1 site in United Kingdom.
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 6 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 4 Nov 2019. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Fridericia's Correction for QT Interval (QTcF) (time frame: 24 hours). 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 4 Nov 2019.