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

NorthSea Therapeutics

Status and phase

Completed

Phase 1

Conditions

Hypertriglyceridemia

Treatments

Drug: Placebo

Drug: NST-1024

Study type

Interventional

Funder types

Industry

Identifiers

NCT04630366

NST-1024-01

Details and patient eligibility

About

A first time in man study of NST-1024

Full 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

Enrollment

96 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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.