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

NCT03577275 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-11-04

Study results available
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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.

Conditions

  • Dyslipidemias

Interventions

DRUG

NST-4016 600mg

Likely maximum therapeutic dose of NST-4016

DRUG

Placebo oral capsule

Placebo for comparison with moxifloxacin and potential NST-4016 effects

DRUG

Moxifloxacin 400mg

Active comparator with known effect on QT interval

DRUG

NST-4016 2000mg

Supratherapeutic dose of NST-4016

Sponsors & Collaborators

  • NorthSea Therapeutics B.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2018-09-15
Completion
2018-09-24
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03577275 on ClinicalTrials.gov