Clinical trial NCT06310876: A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: TQT
Pharmacokinetics
Lead sponsor: Calico Life Sciences LLC
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2024-03-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects
timeFrame: Up to 24 hours
Secondary outcomes:
measure: To evaluate the effects of ABBV-CLS-7262 on change in electrocardiogram (ECG) parameters
timeFrame: Up to 24 hours
measure: To evaluate the sensitivity of QTc measurement using moxifloxacin
timeFrame: Up to 24 hours
measure: To evaluate the effect of ABBV-CLS-7262 on T-wave morphology
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: AbbVie Clinical Pharmacology Research Unit (ACPRU)
state: Illinois
Study officials:
References: