An Investigational Study to Evaluate the Cardiac Safety Assessment (TQTc Study) of ESK-001 (NCT07378579) | Clinical Trial Compass
CompletedPhase 1
An Investigational Study to Evaluate the Cardiac Safety Assessment (TQTc Study) of ESK-001
United States52 participantsStarted 2024-06-21
Plain-language summary
This a phase 1, partially blinded, randomized, crossover study to determine the pharmacokinetics (PK) and QT/QTc interval of study drug (ESK-001) in healthy volunteer participants,
Who can participate
Age range18 Years – 55 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:
* Healthy male and female subjects aged between 18 and 55 years, inclusive. Body mass index between ≥18.0 and ≤32.0 kg/m2, inclusive, and a minimum body weight of 45 kg.
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations, and from the physical examination at screening or check-in, as assessed by the investigator (or designee).
* Serum sodium, potassium, calcium, and magnesium levels are within the normal range at screening and check-in-
Exclusion Criteria:
* Positive hepatitis panel and/or positive human immunodeficiency virus test, hepatitis B surface antigen, or hepatitis C antibodies.
* Alanine aminotransferase or aspartate aminotransferase \>1.5 times the upper limit of normal, at screening or check-in.
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
* Surgery within the past three months prior to the first study drug administration determined by the principal investigator to be clinically relevant.
* 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 are allowed).
* History of Gilbert's syndrome or cholec…
What they're measuring
1
Change from baseline in placebo-adjusted QTcF (∆∆QTcF)