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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06310876
• Other study ID #: M24-852
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 14, 2024
• Est. completion date: June 2024

Study information

• Verified date: June 2024
• Source: Calico Life Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: June 2024
• Est. primary completion date: May 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ABBV-CLS-7262
• single oral Dose 1
• ABBV-CLS-7262
• single oral Dose 2
• Placebo
• single oral dose
• Moxifloxacin 400mg
• single oral dose

Locations

Country	Name	City	State
United States	AbbVie Clinical Pharmacology Research Unit (ACPRU)	Grayslake	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Calico Life Sciences LLC	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	To evaluate the sensitivity of QTc measurement using moxifloxacin	To evaluate the sensitivity of QTc measurement using moxifloxacin.	Up to 24 hours
Secondary	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