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

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577275
• Other study ID #: NST-01
• Status: Completed
• Phase: Phase 1
• Start date: June 15, 2018
• Est. completion date: September 24, 2018

Study information

• Verified date: October 2019
• Source: NorthSea Therapeutics B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 24, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• NST-4016 600mg
Likely maximum therapeutic dose of NST-4016
• Placebo oral capsule
Placebo for comparison with moxifloxacin and potential NST-4016 effects
• Moxifloxacin 400mg
Active comparator with known effect on QT interval
• NST-4016 2000mg
Supratherapeutic dose of NST-4016

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit (CRU) Ltd	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
NorthSea Therapeutics B.V.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Fridericia's Correction for QT Interval (QTcF)	Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)	24 hours
Secondary	Change From Baseline in Heart Rate (HR)	Electrocardiogram measurement of change from baseline in heart rate (HR) maximum values presented	24 hours
Secondary	Change From Baseline in Fridericia's Correction for QT Interval (QTcF)	Electrocardiogram measurement of change from baseline in Fridericia's correction for QT interval (QTcF)	24 hours
Secondary	Change From Baseline in PR Interval (PR)	Electrocardiogram measurement of change from baseline in PR interval (PR)	24 hours
Secondary	Change From Baseline in QRS Interval (QRS)	Electrocardiogram measurement of change from baseline in QRS interval (QRS)	2 hours