Hypertriglyceridemia Clinical Trial
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
Verified date | December 2022 |
Source | NorthSea Therapeutics B.V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A first time in man study of NST-1024
Status | Completed |
Enrollment | 96 |
Est. completion date | June 20, 2022 |
Est. primary completion date | June 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Covance Leeds Clinical Research Unit | Leeds | West Yorkshire |
Lead Sponsor | Collaborator |
---|---|
NorthSea Therapeutics B.V. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability | incidence and severity of adverse events | 4 weeks | |
Secondary | AUC | Area under the PK curve | 3-17 days | |
Secondary | Cmax | Maximum plasma concentration | 3-17 days | |
Secondary | Half life | time to reduction in plasma levels by 50% | 3-17 days |
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