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

A Phase 1, Partially Blinded, Randomized, Crossover Study to Evaluate the Pharmacokinetics and QT/QTc Interval of ESK-001 Compared to Placebo and Moxifloxacin in Healthy Subjects

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,

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: ESK-001; Drug: Placebo; Drug: Moxifloxacin (400 mg)

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.)

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Fortrea CRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment 1: (Therapeutic dose); 1 oral dose of ESK-001	Drug: ESK-001; Single oral dose of ESK-001 in participants
Experimental: Treatment 2: (Supratherapeutic dose); 1 oral dose of ESK-001	Drug: ESK-001; Single oral dose of ESK-001 in participants
Placebo Comparator: Treatment 3: ESK-001-matched placebo	Drug: Placebo; ESK-001-matched placebo
Active Comparator: Treatment 4: (positive control); Moxifloxacin 400 mg tablet	Drug: Moxifloxacin (400 mg); positive control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in placebo-adjusted QTcF (∆∆QTcF)	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations	Up to 22 Days
Composite of pharmacokinetic (PK) parameter Vz/F for ESK-001 and metabolites	24 hours
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

Collaborators and Investigators

• Sponsor: Alumis Inc
• Investigators: Study Director: Jorn Drappa, MD, Ph.D., Alumis Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Moxifloxacin
• Other Study ID Numbers: ESK-001-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The Sponsor Alumis Inc. is a clinical-stage pharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No