Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT04630366
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04630366
Study Brief:
Protocol Section:
NCT04630366