A Phase 1, First Time in Humans Study of NST-1024 | NCT04630366

Studies
A Phase 1, First Time in Humans Study of NST-1024

NCT04630366

Sponsor

NorthSea Therapeutics B.V.

Status

Completed

Last Update Posted

Dec 2, 2022Actual

Enrollment

96Actual

Phase

Phase 1

Conditions

Hypertriglyceridemia

Interventions

NST-1024
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 27, 2020Actual

Primary Completion Date

Jun 20, 2022Actual

Completion Date

Jun 20, 2022Actual

First Submitted Date

Nov 5, 2020

First Submission Date that Met QC Criteria

Nov 10, 2020

First Posted Date

Nov 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2022

Last Update Posted Date

Dec 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A first time in man study of NST-1024

Detailed Description

A Phase 1, First Time in Man Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST-1024 in Healthy Subjects and Otherwise Healthy Subjects with Elevated Triglycerides. This will be a double-blind, randomised, placebo-controlled, single and multiple oral dose study conducted in 2 parts. In part A up to 6 cohorts of 8 healthy volunteers will receive single ascending doses of NST-1024 or matching placebo. I part B up to 4 cohorts of 10 otherwise healthy volunteers, with elevated triglycerides will receive daily multiple ascending doses of NST-1024 for 14 days

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NST-1024	Experimental	NST-1024 capsules given once daily for up to 14 days	Drug: NST-1024
Placebo	Placebo Comparator	Matching placebo capsules to NST-1024 given once daily for up to 14 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NST-1024	Drug	NST-1024	NST-1024
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability	incidence and severity of adverse events	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
AUC	Area under the PK curve	3-17 days
Cmax	Maximum plasma concentration	3-17 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 18-32 kg/m2
In good health
Females will not be pregnant or lactating. Females of childbearing potential must agree to use contraception
Male subjects must agree to use contraception and refrain from donation of sperm
Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Subjects must have TG levels > 150 mg/dL at screening (Part B only).

Exclusion Criteria:

Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, CV, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
Aspartate aminotransferase, ALT, GGT, ALP, or total bilirubin > 1.2 × ULN at Screening or (first) Check-in, confirmed by 1 repeat if necessary
History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.
Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days or 5 half-lives (whichever is longer) prior to dosing.
Use of tobacco- or nicotine-containing products within 1 month prior to Screening, or positive cotinine test at Screening or Check-in.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases