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

Study Overview
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Brief Summary
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A first time in man study of NST-1024

Detailed Description
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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

Official Title
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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

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: NST-1024
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NST-1024<br>NST-1024 capsules given once daily for up to 14 days | Drug: NST-1024<br>* NST-1024<br>|
| Placebo Comparator: Placebo<br>Matching placebo capsules to NST-1024 given once daily for up to 14 days | Drug: Placebo<br>* Matching placebo to NST-1024<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | incidence and severity of adverse events | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | Area under the PK curve | 3-17 days | 
| Cmax | Maximum plasma concentration | 3-17 days | 
| Half life | time to reduction in plasma levels by 50% | 3-17 days |