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

• Status: Completed
• Trial end date: 2018-09-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NorthSea Therapeutics B.V.
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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