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

Calico Life Sciences LLC72 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

ABBV-CLS-7262DRUG

• single oral Dose 1

ABBV-CLS-7262DRUG

• single oral Dose 2

PlaceboDRUG

• single oral dose

Moxifloxacin 400mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

AbbVie Clinical Pharmacology Research Unit (ACPRU)

Grayslake, Illinois, United States

Outcomes

Primary Outcomes

To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects

To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects.

Time frame: Up to 24 hours

Secondary Outcomes

To evaluate the effects of ABBV-CLS-7262 on change in electrocardiogram (ECG) parameters

ECG parameters include RR and PR interval, QRS duration and heart rate (HR).

Time frame: Up to 24 hours

To evaluate the sensitivity of QTc measurement using moxifloxacin

To evaluate the sensitivity of QTc measurement using moxifloxacin.

Time frame: Up to 24 hours

To evaluate the effect of ABBV-CLS-7262 on T-wave morphology

To evaluate the effect of ABBV-CLS-7262 on T-wave morphology.

Time frame: Up to 24 hours

Data from ClinicalTrials.gov

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