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Completed

NCT Number: NCT03577275

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

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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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit (CRU) Ltd

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NST-4016 600mg

Drug

Likely maximum therapeutic dose of NST-4016

Other names: Icosabutate

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

Other names: Icosabutate

Primary outcomes

  1. Change From Baseline in Fridericia's Correction for QT Interval (QTcF)

    Time frame: 24 hours

    Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)

Secondary outcomes

  1. Change From Baseline in Heart Rate (HR)

    Time frame: 24 hours

    Electrocardiogram measurement of change from baseline in heart rate (HR) maximum values presented

  2. Change From Baseline in Fridericia's Correction for QT Interval (QTcF)

    Time frame: 24 hours

    Electrocardiogram measurement of change from baseline in Fridericia's correction for QT interval (QTcF)

  3. Change From Baseline in PR Interval (PR)

    Time frame: 24 hours

    Electrocardiogram measurement of change from baseline in PR interval (PR)

  4. Change From Baseline in QRS Interval (QRS)

    Time frame: 2 hours

    Electrocardiogram measurement of change from baseline in QRS interval (QRS)

Sponsors and collaborators

Lead sponsor

NorthSea Therapeutics B.V.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 5, 2018
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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