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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2018-09-24

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.

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Detailed Description

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Conditions

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Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo oral capsule

Single dose of placebo to match NST-4016

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo for comparison with moxifloxacin and potential NST-4016 effects

Moxifloxacin 400mg

Single 400mg dose of active comparator moxifloxacin (open label)

Group Type ACTIVE_COMPARATOR

Moxifloxacin 400mg

Intervention Type DRUG

Active comparator with known effect on QT interval

NST-4016 600mg

Likely therapeutic dose of NST-4016

Group Type EXPERIMENTAL

NST-4016 600mg

Intervention Type DRUG

Likely maximum therapeutic dose of NST-4016

NST-4016 2000mg

Supratherapeutic dose of NST-4016

Group Type EXPERIMENTAL

NST-4016 2000mg

Intervention Type DRUG

Supratherapeutic dose of NST-4016

Interventions

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NST-4016 600mg

Likely maximum therapeutic dose of NST-4016

Intervention Type DRUG

Placebo oral capsule

Placebo for comparison with moxifloxacin and potential NST-4016 effects

Intervention Type DRUG

Moxifloxacin 400mg

Active comparator with known effect on QT interval

Intervention Type DRUG

NST-4016 2000mg

Supratherapeutic dose of NST-4016

Intervention Type DRUG

Other Intervention Names

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Icosabutate Icosabutate

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes