The effect of NST-4016 on QT/QTc interval in Healthy Volunteers
Research type
Research Study
Full title
A Randomized, 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 Volunteers
IRAS ID
242730
Contact name
Ashley Brooks
Contact email
Sponsor organisation
NorthSea Therapeutics BV
Eudract number
2018-000395-14
Duration of Study in the UK
0 years, 3 months, 17 days
Research summary
Icosabutate is a new oral medication developed by Northsea therapeutics for the treatment of people with high blood cholesterol and a type of fat called triglycerides. These fats have been shown to have a relationship with heart disease and inflammation of the pancreas.
Icosabutate is derived from a naturally occurring omega-3 fatty acid and modified which helps increase the natural effect of omega -3 fatty acids, and prevents fats associated with heart disease being converted into their harmful versions by the liver.
Icosabutate has been shown to reduce triglycerides and cholesterol levels in the blood it does this by activating a receptor found on a number of organs which is a major regulator of cholesterol and glucose in the blood.
The purpose of the study is to assess the effects of therapeutic and supratherapeutic (high) doses of the study drug on the heart by assessing subjects ECG’s.
There will be 32 subjects randomised. Subjects will receive one of four different treatment regimens, and the population of subjects will be healthy males and females.
They will take each of the following four treatments as a single dose, with a 5 day period between each dosing.
• Therapeutic dose of icosabutate (600mg)
• Supratherapeutic dose of icosabutate (2000mg)
• Moxifloxacin
• Placebo
Subjects will be resident in the clinical research unit for a total of 19 days. The total duration of study participation will be approximately 8 weeks.REC name
North East - York Research Ethics Committee
REC reference
18/NE/0114
Date of REC Opinion
11 May 2018
REC opinion
Favourable Opinion