An Investigational Study to Evaluate the Cardiac Safety Assessment (TQTc Study) of ESK-001

Alumis

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Moxifloxacin (400 mg); Drug: ESK-001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07378579

ESK-001-019

Details and patient eligibility

About

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,

Full 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.)

Enrollment: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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52 participants in 4 patient groups, including a placebo group

Treatment 1: (Therapeutic dose)

Experimental group

Description:

1 oral dose of ESK-001

Treatment:

Drug: ESK-001

Treatment 2: (Supratherapeutic dose)

Experimental group

Description:

1 oral dose of ESK-001

Treatment:

Drug: ESK-001

Treatment 3: ESK-001-matched placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Treatment 4: (positive control)

Active Comparator group

Description:

Moxifloxacin 400 mg tablet

Treatment:

Drug: Moxifloxacin (400 mg)