Clinical trial NCT04630366: A Phase 1, First Time in Humans Study of NST-1024
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertriglyceridemia
Lead sponsor: NorthSea Therapeutics B.V.
Sponsor class: INDUSTRY
First posted: 2020-11-16
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Safety and tolerability
timeFrame: 4 weeks
Secondary outcomes:
measure: AUC
timeFrame: 3-17 days
measure: Cmax
timeFrame: 3-17 days
measure: Half life
timeFrame: 3-17 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Leeds Clinical Research Unit
state: West Yorkshire
Study officials:
References: