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

NorthSea Therapeutics

Status and phase: Completed; Phase 1

Conditions: Dyslipidemias

Treatments: Drug: Placebo oral capsule; Drug: Moxifloxacin 400mg; Drug: NST-4016 600mg; Drug: NST-4016 2000mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03577275

NST-01

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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32 participants in 4 patient groups, including a placebo group

Placebo oral capsule

Placebo Comparator group

Description:

Single dose of placebo to match NST-4016

Treatment:

Drug: Placebo oral capsule

Moxifloxacin 400mg

Active Comparator group

Description:

Single 400mg dose of active comparator moxifloxacin (open label)

Treatment:

Drug: Moxifloxacin 400mg

NST-4016 600mg

Experimental group

Description:

Likely therapeutic dose of NST-4016

Treatment:

Drug: NST-4016 600mg

NST-4016 2000mg

Experimental group

Description:

Supratherapeutic dose of NST-4016

Treatment:

Drug: NST-4016 2000mg