An Investigational Study to Evaluate the Cardiac Safety Assessment (TQTc Study) of ESK-001
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteer
In brief
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,
Key facts
- Study ID
- NCT07378579
- Run by
- Alumis Inc
- People needed
- 52
- Starts
- 2024-06-21
- Expected to finish
- 2024-08-31
- Last updated by the study team
- 2026-01-30
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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-
You may not qualify if…
- 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 cholecystectomy surgery.
Where it is running
- Fortrea CRU — Daytona Beach, Florida, United States
Full record on ClinicalTrials.gov
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