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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06310876

Enrollment

Registered

2024-03-15

Start date

2024-03-14

Completion date

2024-06-26

Last updated

2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

TQT, Pharmacokinetics

Brief 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.

Interventions

DRUGABBV-CLS-7262

• single oral Dose 1

DRUGPlacebo

• single oral dose

DRUGMoxifloxacin 400mg

• single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Adult volunteers in general good health. * Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. * Individuals between 18 and 55 years of age inclusive at the time of screening. * Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 * All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug. * All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.

Exclusion criteria

* Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures * Pregnant or breastfeeding. * Treatment with any other investigational treatment within 30 days

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects	Up to 24 hours	To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects.

Secondary

Measure	Time frame	Description
To evaluate the effects of ABBV-CLS-7262 on change in electrocardiogram (ECG) parameters	Up to 24 hours	ECG parameters include RR and PR interval, QRS duration and heart rate (HR).
To evaluate the sensitivity of QTc measurement using moxifloxacin	Up to 24 hours	To evaluate the sensitivity of QTc measurement using moxifloxacin.
To evaluate the effect of ABBV-CLS-7262 on T-wave morphology	Up to 24 hours	To evaluate the effect of ABBV-CLS-7262 on T-wave morphology.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026