Healthy Volunteer
Conditions
Brief 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,
Detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Interventions
DRUGESK-001
Single oral dose of ESK-001 in participants
positive control
DRUGPlacebo
ESK-001-matched placebo
Sponsors
Alumis Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
All subjects will be randomized to 1 of 4 treatment sequences; each subject will receive all 4 treatments. Treatments 1 through 3 will be blinded; Treatment 4 will be given open label. The central ECG laboratory will be blinded to treatment assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 cholecystectomy surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in placebo-adjusted QTcF (∆∆QTcF) | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Composite of pharmacokinetic (PK) parameter Cmax for ESK-001 and metabolites | 24 hours |
| Composite of pharmacokinetic (PK) parameter tmax for ESK-001 and metabolites | 24 hours |
| Composite of pharmacokinetic (PK) parameter CL/F for ESK-001 and metabolites | 24 hours |
| Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations | Up to 22 Days |
| Change from baseline in ECG parameter ΔHR | 24 hours |
| Change from baseline in ECG parameter Δ PR interval | 24 hours |
| Change from baseline in ECG parameter ΔQRS duration | 24 hours |
| Change from baseline in ECG parameter ΔQTc interval | 24 hours |
| Composite of pharmacokinetic (PK) parameter Vz/F for ESK-001 and metabolites | 24 hours |
| Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation | Up to 22 Days |
Countries
United States
Contacts
STUDY_DIRECTORJorn Drappa, MD, Ph.D.
Alumis Inc
Outcome results
None listed