A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT06310876
- Run by
- Calico Life Sciences LLC
- People needed
- 72
- Starts
- 2024-03-14
- Expected to finish
- 2024-06-26
- Last updated by the study team
- 2024-07-01
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- AbbVie Clinical Pharmacology Research Unit (ACPRU) — Grayslake, Illinois, United States
Full record on ClinicalTrials.gov
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