At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
NST-4016 600mg +3 moredrug
Likely dose
NST-4016 600mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating NST-4016 600mg, Placebo oral capsule, and 2 other interventions for Dyslipidemias. Completed, enrolled 32 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemias
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartJun 2018
First PostedJul 2018
Primary CompletionSep 2018
Study CompletionSep 2018
TodayJul 2026
First PostedJul 5, 2018
Enrollment StartJun 15, 2018
Primary CompletionSep 15, 2018
Study CompletionSep 24, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.0 years ago
Interventions
NST-4016 600mgdrug
Likely maximum therapeutic dose of NST-4016
Placebo oral capsuledrug
Placebo for comparison with moxifloxacin and potential NST-4016 effects
Moxifloxacin 400mgdrug
Active comparator with known effect on QT interval
NST-4016 2000mgdrug
Supratherapeutic dose of NST-4016