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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemias
• Intervention / Treatment: Drug: Placebo oral capsule; Drug: Moxifloxacin 400mg; Drug: NST-4016 600mg; Drug: NST-4016 2000mg

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Covance Clinical Research Unit (CRU) Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo oral capsule; Single dose of placebo to match NST-4016	Drug: Placebo oral capsule; Placebo for comparison with moxifloxacin and potential NST-4016 effects
ACTIVE_COMPARATOR: Moxifloxacin 400mg; Single 400mg dose of active comparator moxifloxacin (open label)	Drug: Moxifloxacin 400mg; Active comparator with known effect on QT interval
EXPERIMENTAL: NST-4016 600mg; Likely therapeutic dose of NST-4016	Drug: NST-4016 600mg; Likely maximum therapeutic dose of NST-4016; Other Names: Icosabutate
EXPERIMENTAL: NST-4016 2000mg; Supratherapeutic dose of NST-4016	Drug: NST-4016 2000mg; Supratherapeutic dose of NST-4016; Other Names: Icosabutate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: NorthSea Therapeutics B.V.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2018
• Primary Completion (ACTUAL): September 15, 2018
• Study Completion (ACTUAL): September 24, 2018

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (ACTUAL): July 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: NST-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No