A Phase 1, First Time in Humans Study of NST-1024 (NCT04630366) | Clinical Trial Compass
CompletedPhase 1
A Phase 1, First Time in Humans Study of NST-1024
United Kingdom96 participantsStarted 2020-10-27
Plain-language summary
A first time in man study of NST-1024
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wit…