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

Phase 1

Completed

• Conditions: Dyslipidemias
• Interventions: Drug: Placebo oral capsule; Drug: Moxifloxacin 400mg; Drug: NST-4016 600mg; Drug: NST-4016 2000mg

• Registration Number: NCT03577275
• Lead Sponsor: NorthSea Therapeutics B.V.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-15
• Study First Submitted: 2018-06-22
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-05
• Primary Completion: 2018-09-15
• Study Completion: 2018-09-24
• Results First Submitted: 2019-07-31
• Status Verified: 2019-10
• Results First Submitted QC: 2019-11-01
• Last Update Submitted: 2019-11-01
• Results First Posted: 2019-11-04
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo oral capsule	Placebo oral capsule	Single dose of placebo to match NST-4016
Moxifloxacin 400mg	Moxifloxacin 400mg	Single 400mg dose of active comparator moxifloxacin (open label)
NST-4016 600mg	NST-4016 600mg	Likely therapeutic dose of NST-4016
NST-4016 2000mg	NST-4016 2000mg	Supratherapeutic dose of NST-4016

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Fridericia's Correction for QT Interval (QTcF)	24 hours	Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Heart Rate (HR)	24 hours	Electrocardiogram measurement of change from baseline in heart rate (HR) maximum values presented
Change From Baseline in Fridericia's Correction for QT Interval (QTcF)	24 hours	Electrocardiogram measurement of change from baseline in Fridericia's correction for QT interval (QTcF)
Change From Baseline in PR Interval (PR)	24 hours	Electrocardiogram measurement of change from baseline in PR interval (PR)
Change From Baseline in QRS Interval (QRS)	2 hours	Electrocardiogram measurement of change from baseline in QRS interval (QRS)

Trial Locations

Locations (1)

Covance Clinical Research Unit (CRU) Ltd; 🇬🇧 Leeds, United Kingdom