Overview

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