A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: NST-4016 600mg
* Drug: Placebo oral capsule
* Drug: Moxifloxacin 400mg
* Drug: NST-4016 2000mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo oral capsule<br>Single dose of placebo to match NST-4016 | Drug: Placebo oral capsule<br>* Placebo for comparison with moxifloxacin and potential NST-4016 effects<br>|
| Active Comparator: Moxifloxacin 400mg<br>Single 400mg dose of active comparator moxifloxacin (open label) | Drug: Moxifloxacin 400mg<br>* Active comparator with known effect on QT interval<br>|
| Experimental: NST-4016 600mg<br>Likely therapeutic dose of NST-4016 | Drug: NST-4016 600mg<br>* Likely maximum therapeutic dose of NST-4016<br>* Other names: Icosabutate;|
| Experimental: NST-4016 2000mg<br>Supratherapeutic dose of NST-4016 | Drug: NST-4016 2000mg<br>* Supratherapeutic dose of NST-4016<br>* Other names: Icosabutate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Heart Rate (HR) | Electrocardiogram measurement of change from baseline in heart rate (HR) maximum values presented | 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) | 24 hours | 
| Change From Baseline in PR Interval (PR) | Electrocardiogram measurement of change from baseline in PR interval (PR) | 24 hours | 
| Change From Baseline in QRS Interval (QRS) | Electrocardiogram measurement of change from baseline in QRS interval (QRS) | 2 hours |