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

NCT07378579 | Completed Phase 1 FDA Drug

• 1 other identifier: ESK-001-019
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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,

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Change from baseline in placebo-adjusted QTcF (∆∆QTcF)

  24 hours

Secondary Outcomes (10)

• 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

• Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation

  Up to 22 Days

Study Arms (4)

Treatment 1: (Therapeutic dose)

EXPERIMENTAL

1 oral dose of ESK-001

Drug: ESK-001

Treatment 2: (Supratherapeutic dose)

EXPERIMENTAL

1 oral dose of ESK-001

Drug: ESK-001

Treatment 3: ESK-001-matched placebo

PLACEBO COMPARATOR

Drug: Placebo

Treatment 4: (positive control)

ACTIVE COMPARATOR

Moxifloxacin 400 mg tablet

Drug: Moxifloxacin (400 mg)

Interventions

ESK-001 DRUG

Single oral dose of ESK-001 in participants

Treatment 1: (Therapeutic dose); Treatment 2: (Supratherapeutic dose)

Moxifloxacin (400 mg) DRUG

positive control

Treatment 4: (positive control)

Placebo DRUG

ESK-001-matched placebo

Treatment 3: ESK-001-matched placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Alumis Inc: lead

Study Sites (1)

Fortrea CRU

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jorn Drappa, MD, Ph.D.

  Alumis Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 30, 2026
• Study Start: June 21, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

US (1)