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

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630366
• Other study ID #: NST-1024-01
• Status: Completed
• Phase: Phase 1
• Start date: October 27, 2020
• Est. completion date: June 20, 2022

Study information

• Verified date: December 2022
• Source: NorthSea Therapeutics B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A first time in man study of NST-1024

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• NST-1024
NST-1024
• Placebo
Matching placebo to NST-1024

Locations

Country	Name	City	State
United Kingdom	Covance Leeds Clinical Research Unit	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
NorthSea Therapeutics B.V.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	incidence and severity of adverse events	4 weeks
Secondary	AUC	Area under the PK curve	3-17 days
Secondary	Cmax	Maximum plasma concentration	3-17 days
Secondary	Half life	time to reduction in plasma levels by 50%	3-17 days