NCT03577275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 4, 2019

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

June 22, 2018

Results QC Date

July 31, 2019

Last Update Submit

November 1, 2019

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change From Baseline in Heart Rate (HR)

    24 hours

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

    24 hours

  • Change From Baseline in PR Interval (PR)

    24 hours

  • Change From Baseline in QRS Interval (QRS)

    2 hours

Study Arms (4)

Placebo oral capsule

PLACEBO COMPARATOR

Single dose of placebo to match NST-4016

Drug: Placebo oral capsule

Moxifloxacin 400mg

ACTIVE COMPARATOR

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

Drug: Moxifloxacin 400mg

NST-4016 600mg

EXPERIMENTAL

Likely therapeutic dose of NST-4016

Drug: NST-4016 600mg

NST-4016 2000mg

EXPERIMENTAL

Supratherapeutic dose of NST-4016

Drug: NST-4016 2000mg

Interventions

NST-4016 600mgDRUG

Likely maximum therapeutic dose of NST-4016

Also known as: Icosabutate
NST-4016 600mg
Placebo oral capsuleDRUG

Placebo for comparison with moxifloxacin and potential NST-4016 effects

Placebo oral capsule
Moxifloxacin 400mgDRUG

Active comparator with known effect on QT interval

Moxifloxacin 400mg
NST-4016 2000mgDRUG

Supratherapeutic dose of NST-4016

Also known as: Icosabutate
NST-4016 2000mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
  • \. Body mass index (BMI) between 18.0 and 33.0 kg/m2, inclusive, at Screening
  • \. In good health

You may not qualify if:

  • \. An uninterpretable or abnormal ECG at Screening and/or Check in
  • \. History of risk factors for Torsades de Pointes
  • \. sustained supine systolic blood pressure \>140 mmHg or \<90 mmHg
  • \. Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
  • \. Female subjects who are pregnant (or planning to become pregnant within 90 days after the final dose administration) or are currently lactating
  • \. Subjects who, in the opinion of the Investigator (or designee), should not participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit (CRU) Ltd

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

icosabutateMoxifloxacin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr Patrick Round
Organization
NorthSea Therapeutics BV
patrick.round@northseatherapeutics.com
+44(0)7979502770

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 5, 2018

Study Start

June 15, 2018

Primary Completion

September 15, 2018

Study Completion

September 24, 2018

Last Updated

November 4, 2019

Results First Posted

November 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)