NCT03577275

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: NorthSea Therapeutics B.V. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-06-15
• Primary completion: 2018-09-15
• Completion: 2018-09-24
• First posted: 2018-07-05
• Last updated: 2019-11-04
• Results posted: 2019-11-04

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study