NCT07378579

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Alumis Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.)

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	ESK-001	Single oral dose of ESK-001 in participants
DRUG	Moxifloxacin (400 mg)	positive control
DRUG	Placebo	ESK-001-matched placebo

Timeline

• Start date: 2024-06-21
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study