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A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval
Phase 1 trial testing NST-4016 600mg in Dyslipidemias in 32 participants. Completed in 24 September 2018.
| Lead sponsor | NorthSea Therapeutics B.V. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 15 June 2018 |
| Primary completion | 15 September 2018 |
| Estimated completion | 24 September 2018 |
| Sites | 1 location across United Kingdom |
NorthSea Therapeutics B.V. — full company profile →
Adults 18 to 55, any sex, with Dyslipidemias. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)
| Group | Value | 95% CI |
|---|---|---|
| Placebo Oral Capsule | -4.6 | ± 1.52 |
| Moxifloxacin 400mg | 11.5 | ± 0.88 |
| NST-4016 600mg | -6.0 | ± 1.39 |
| NST-4016 2000mg | -6.1 | ± 1.42 |
Electrocardiogram measurement of change from baseline in heart rate (HR) maximum values presented
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 9.9 | ± 0.86 |
| Moxifloxacin 400mg | 12.2 | ± 0.85 |
| NST-4016 600mg | 12.6 | ± 0.88 |
| NST-4016 2000mg | 15.6 | ± 0.85 |
Electrocardiogram measurement of change from baseline in Fridericia's correction for QT interval (QTcF)
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -4.6 | ± 1.52 |
| Moxifloxacin 400mg | 11.5 | ± 0.88 |
| NST-4016 600mg | -6.0 | ± 1.39 |
| NST-4016 2000mg | -5.7 | ± 1.39 |
Electrocardiogram measurement of change from baseline in PR interval (PR)
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -11.0 | ± 1.32 |
| Moxifloxacin 400mg | -11.9 | ± 1.30 |
| NST-4016 600mg | -11.4 | ± 1.36 |
| NST-4016 2000mg | -12.4 | ± 1.30 |
Electrocardiogram measurement of change from baseline in QRS interval (QRS)
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.2 | ± 0.17 |
| Moxifloxacin 400mg | -0.1 | ± 0.16 |
| NST-4016 600mg | -0.2 | ± 0.17 |
| NST-4016 2000mg | 0.2 | ± 0.16 |
Time frame: 3.5 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo Oral Capsule | Moxifloxacin 400mg | NST-4016 600mg | NST-4016 2000mg |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | — | — | — | — |
| Reaction | System | Placebo Oral Capsule | Moxifloxacin 400mg | NST-4016 600mg | NST-4016 2000mg |
|---|---|---|---|---|---|
| Gastrointestinal disturbance | Gastrointestinal disorders | — | — | — | — |
Most-reported serious reactions: Cerebrovascular accident.
Data from ClinicalTrials.gov NCT03577275 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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