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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo oral capsule | Placebo Comparator | Single dose of placebo to match NST-4016 |
|
| Moxifloxacin 400mg | Active Comparator | Single 400mg dose of active comparator moxifloxacin (open label) |
|
| NST-4016 600mg | Experimental | Likely therapeutic dose of NST-4016 |
|
| NST-4016 2000mg | Experimental | Supratherapeutic dose of NST-4016 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NST-4016 600mg | Drug | Likely maximum therapeutic dose of NST-4016 |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit (CRU) Ltd | Leeds | LS2 9LH | United Kingdom |
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This was a cross over study so 32 subjects each completed 4 treatment arms
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | This was a 4 way crossover study in which all study participants received the following treatments in random order; NST-4016 2000mg: Supratherapeutic dose of NST-4016, NST-4016 600mg: Likely maximum therapeutic dose of NST-4016, Moxifloxacin 400mg: Active comparator with known effect on QT interval, Placebo oral capsule: Placebo for comparison with moxifloxacin and potential NST-4016 effects. There were 12 possible treatment sequences |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants were randomized to receive all 4 interventions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | The primary endpoint for this trial was the placebo corrected change from baseline in QTcF. The data presented here are the maximum absolute change from baseline for placebo, moxifloxacin 400mg, NST-4016 600mg and NST-4016 2000mg. | Posted | Least Squares Mean | Standard Error | msec | 24 hours |
|
3.5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Oral Capsule | Single dose of placebo to match NST-4016 Placebo oral capsule: Placebo for comparison with moxifloxacin and potential NST-4016 effects |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment | One subject (female) experienced an SAE of cerebrovascular accident that began <17 days post the last dose of the study drug (600 mg icosabutate in Dosing Period 4). The Investigator considered the event to be severe and related to the study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disturbance | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Patrick Round | NorthSea Therapeutics BV | +44(0)7979502770 | patrick.round@northseatherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2018 | Jul 31, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2018 | Jul 31, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000626078 | icosabutate |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo oral capsule | Drug | Placebo for comparison with moxifloxacin and potential NST-4016 effects |
|
| Moxifloxacin 400mg | Drug | Active comparator with known effect on QT interval |
|
| NST-4016 2000mg | Drug | Supratherapeutic dose of NST-4016 |
|
|
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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Single 400mg dose of active comparator moxifloxacin (open label) Moxifloxacin 400mg: Active comparator with known effect on QT interval |
| OG002 | NST-4016 600mg | Likely therapeutic dose of NST-4016 NST-4016 600mg: Likely maximum therapeutic dose of NST-4016 |
| OG003 | NST-4016 2000mg | Supratherapeutic dose of NST-4016 NST-4016 2000mg: Supratherapeutic dose of NST-4016 |
|
|
|
| Secondary | Change From Baseline in Heart Rate (HR) | Electrocardiogram measurement of change from baseline in heart rate (HR) maximum values presented | maximum values of change in heart rate from baseline over the 24 hours post dose | Posted | Least Squares Mean | Standard Error | beats per minute | 24 hours |
|
|
|
| Secondary | 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) | The largest change in QTcF for each arm during the study is presented below | Posted | Least Squares Mean | Standard Error | msec | 24 hours |
|
|
|
| Secondary | Change From Baseline in PR Interval (PR) | Electrocardiogram measurement of change from baseline in PR interval (PR) | maximum change from baseline during the study period is reported | Posted | Least Squares Mean | Standard Error | msec | 24 hours |
|
|
|
| Secondary | Change From Baseline in QRS Interval (QRS) | Electrocardiogram measurement of change from baseline in QRS interval (QRS) | The data presented is from the 2 hour time point corresponding to T max | Posted | Least Squares Mean | Standard Error | msec | 2 hours |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 4 |
| 32 |
| EG001 | Moxifloxacin 400mg | Single 400mg dose of active comparator moxifloxacin (open label) Moxifloxacin 400mg: Active comparator with known effect on QT interval | 0 | 32 | 0 | 32 | 6 | 32 |
| EG002 | NST-4016 600mg | Likely therapeutic dose of NST-4016 NST-4016 600mg: Likely maximum therapeutic dose of NST-4016 | 0 | 32 | 0 | 32 | 4 | 32 |
| EG003 | NST-4016 2000mg | Supratherapeutic dose of NST-4016 NST-4016 2000mg: Supratherapeutic dose of NST-4016 | 0 | 32 | 1 | 32 | 15 | 32 |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |