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

Phase 1

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Placebo; Drug: NST-1024

• Registration Number: NCT04630366
• Lead Sponsor: NorthSea Therapeutics B.V.

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

Study Timeline

• Study Start: 2020-10-27
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-10
• Study First Posted: 2020-11-16
• Primary Completion: 2022-06-20
• Study Completion: 2022-06-20
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo capsules to NST-1024 given once daily for up to 14 days
NST-1024	NST-1024	NST-1024 capsules given once daily for up to 14 days

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	4 weeks	incidence and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
AUC	3-17 days	Area under the PK curve
Cmax	3-17 days	Maximum plasma concentration
Half life	3-17 days	time to reduction in plasma levels by 50%

Trial Locations

Locations (1)

Covance Leeds Clinical Research Unit; 🇬🇧 Leeds, West Yorkshire, United Kingdom