NCT06310876

A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects

A Phase 1 Placebo-and Active-Controlled Crossover Study of the Potential for Cardiac Repolarization Effects Following Single Dose of ABBV-CLS-7262 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Calico Life Sciences LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, blinded, placebo and active-controlled, 4-period, crossover design thorough QT/QTc (TQT) study to evaluate the effect of ABBV-CLS-7262 on cardiac repolarization in healthy adult subjects.

Detailed description

This is a randomized, blinded, placebo and active-controlled, 4-period, crossover study. The study will be double-blinded for ABBV-CLS-7262 (dose 1 or dose 2) and placebo regimens and open-label for moxifloxacin. 72 subjects are planned to be enrolled. All subjects will receive a single oral dose of 4 different study treatments over 4 separate treatment periods, each separated by a washout period. On Day 1 of each period, subjects will receive either ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg. In each period, cardiodynamic ECGs will be collected pre-dose and for 24 hours post-dose and PK blood samples will be collected pre-dose and for 48 hours post-dose. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ABBV-CLS-7262	• single oral Dose 1
DRUG	ABBV-CLS-7262	• single oral Dose 2
DRUG	Placebo	• single oral dose
DRUG	Moxifloxacin 400mg	• single oral dose

Timeline

• Start date: 2024-03-14
• Primary completion: 2024-05-29
• Completion: 2024-06-26
• First posted: 2024-03-15
• Last updated: 2024-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study