Title
A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval
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
Phase
Phase 1Lead Sponsor
NorthSea Therapeutics B.V.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
DyslipidemiasIntervention/Treatment
NST-4016 600mg Moxifloxacin 400mg NST-4016 2000mg ...Study Participants
32This 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.
Placebo for comparison with moxifloxacin and potential NST-4016 effects
Active comparator with known effect on QT interval
Single dose of placebo to match NST-4016
Single 400mg dose of active comparator moxifloxacin (open label)
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
| Event Type | Organ System | Event Term | Placebo Oral Capsule | Moxifloxacin 400mg | NST-4016 600mg | NST-4016 2000mg |
|---|
Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)
Electrocardiogram measurement of change from baseline in heart rate (HR) maximum values presented
Electrocardiogram measurement of change from baseline in Fridericia's correction for QT interval (QTcF)
Electrocardiogram measurement of change from baseline in PR interval (PR)
Electrocardiogram measurement of change from baseline in QRS interval (QRS)
