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

Primary Purpose

Dyslipidemias

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

NST-4016 600mg

Placebo oral capsule

Moxifloxacin 400mg

NST-4016 2000mg

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

Covance Clinical Research Unit (CRU) Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo oral capsule

Moxifloxacin 400mg

NST-4016 600mg

NST-4016 2000mg

Arm Description

Single dose of placebo to match NST-4016

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

Likely therapeutic dose of NST-4016

Supratherapeutic dose of NST-4016

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change From Baseline in Heart Rate (HR)

Electrocardiogram measurement of change from baseline in heart rate (HR) maximum values presented

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)

Change From Baseline in PR Interval (PR)

Electrocardiogram measurement of change from baseline in PR interval (PR)

Change From Baseline in QRS Interval (QRS)

Electrocardiogram measurement of change from baseline in QRS interval (QRS)

Full Information

NCT ID

NCT03577275

First Posted

June 22, 2018

Last Updated

November 1, 2019

Sponsor

NorthSea Therapeutics B.V.

1. Study Identification

Unique Protocol Identification Number

NCT03577275

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

June 15, 2018 (Actual)

Primary Completion Date

September 15, 2018 (Actual)

Study Completion Date

September 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NorthSea Therapeutics B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo oral capsule

Arm Type

Placebo Comparator

Arm Description

Single dose of placebo to match NST-4016

Arm Title

Moxifloxacin 400mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

NST-4016 600mg

Arm Type

Experimental

Arm Description

Likely therapeutic dose of NST-4016

Arm Title

NST-4016 2000mg

Arm Type

Experimental

Arm Description

Supratherapeutic dose of NST-4016

Intervention Type

Drug

Intervention Name(s)

NST-4016 600mg

Other Intervention Name(s)

Icosabutate

Intervention Description

Likely maximum therapeutic dose of NST-4016

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Intervention Description

Placebo for comparison with moxifloxacin and potential NST-4016 effects

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin 400mg

Intervention Description

Active comparator with known effect on QT interval

Intervention Type

Drug

Intervention Name(s)

NST-4016 2000mg

Other Intervention Name(s)

Icosabutate

Intervention Description

Supratherapeutic dose of NST-4016

Primary Outcome Measure Information:

Title

Change From Baseline in Fridericia's Correction for QT Interval (QTcF)

Description

Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Change From Baseline in Heart Rate (HR)

Description

Electrocardiogram measurement of change from baseline in heart rate (HR) maximum values presented

Time Frame

24 hours

Title

Change From Baseline in Fridericia's Correction for QT Interval (QTcF)

Description

Electrocardiogram measurement of change from baseline in Fridericia's correction for QT interval (QTcF)

Time Frame

24 hours

Title

Change From Baseline in PR Interval (PR)

Description

Electrocardiogram measurement of change from baseline in PR interval (PR)

Time Frame

24 hours

Title

Change From Baseline in QRS Interval (QRS)

Description

Electrocardiogram measurement of change from baseline in QRS interval (QRS)

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Covance Clinical Research Unit (CRU) Ltd

City

Leeds

ZIP/Postal Code

LS2 9LH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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