Phase 1
N=32
A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval
Dyslipidemias
Bottom Line
View on ClinicalTrials.gov: NCT03577275 ↗Enrolled (actual)
32
Serious AEs
0.8%
Results posted
Nov 2019
Primary outcome: Primary: Change From Baseline in Fridericia's Correction for QT Interval (QTcF) — -4.6; 11.5; -6.0; -6.1 msec
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- NST-4016 600mg (Drug); Placebo oral capsule (Drug); Moxifloxacin 400mg (Drug); NST-4016 2000mg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- NorthSea Therapeutics B.V.
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Fridericia's Correction for QT Interval (QTcF) |
-4.6; 11.5; -6.0; -5.7 | — |
| SECONDARY Change From Baseline in Heart Rate (HR) |
9.9; 12.2; 12.6; 15.6 | — |
| SECONDARY Change From Baseline in Fridericia's Correction for QT Interval (QTcF) |
-4.6; 11.5; -6.0; -5.7 | — |
| SECONDARY Change From Baseline in PR Interval (PR) |
-11.0; -11.9; -11.4; -12.4 | — |
| SECONDARY Change From Baseline in QRS Interval (QRS) |
-0.2; -0.1; -0.2; 0.2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03577275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.