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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ABBV-CLS-7262; Drug: ABBV-CLS-7262; Drug: Placebo; Drug: Moxifloxacin 400mg

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • AbbVie Clinical Pharmacology Research Unit (ACPRU)

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet	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
Experimental: Sequence 2; Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet	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
Experimental: Sequence 3; Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet	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
Experimental: Sequence 4; Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 24 hours
To evaluate the sensitivity of QTc measurement using moxifloxacin	To evaluate the sensitivity of QTc measurement using moxifloxacin.	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.	Up to 24 hours

Collaborators and Investigators

• Sponsor: Calico Life Sciences LLC
• Collaborators: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Actual): May 29, 2024
• Study Completion (Actual): June 26, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; TQT
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: M24-852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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