Hypertriglyceridemia
Conditions
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
Interventions
DRUGNST-1024
NST-1024
DRUGPlacebo
Matching placebo to NST-1024
Sponsors
NorthSea Therapeutics B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | 4 weeks | incidence and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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% |
Countries
United Kingdom
Outcome results
None listed