A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects (NCT06310876) | Clinical Trial Compass
CompletedPhase 1
A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects
United States72 participantsStarted 2024-03-14
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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
What they're measuring
1
To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects