A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects
NCT ID: NCT06310876
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2024-03-14
2024-06-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Sequence 1
Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet
ABBV-CLS-7262
• single oral Dose 1
ABBV-CLS-7262
• single oral Dose 2
Placebo
• single oral dose
Moxifloxacin 400mg
• single oral dose
Sequence 2
Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet
ABBV-CLS-7262
• single oral Dose 1
ABBV-CLS-7262
• single oral Dose 2
Placebo
• single oral dose
Moxifloxacin 400mg
• single oral dose
Sequence 3
Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet
ABBV-CLS-7262
• single oral Dose 1
ABBV-CLS-7262
• single oral Dose 2
Placebo
• single oral dose
Moxifloxacin 400mg
• single oral dose
Sequence 4
Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet
ABBV-CLS-7262
• single oral Dose 1
ABBV-CLS-7262
• single oral Dose 2
Placebo
• single oral dose
Moxifloxacin 400mg
• single oral dose
Interventions
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ABBV-CLS-7262
• single oral Dose 1
ABBV-CLS-7262
• single oral Dose 2
Placebo
• single oral dose
Moxifloxacin 400mg
• single oral dose
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant or breastfeeding.
* Treatment with any other investigational treatment within 30 days
18 Years
55 Years
ALL
Yes
Sponsors
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AbbVie
INDUSTRY
Calico Life Sciences LLC
INDUSTRY
Responsible Party
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Locations
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AbbVie Clinical Pharmacology Research Unit (ACPRU)
Grayslake, Illinois, United States
Countries
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Other Identifiers
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M24-852
Identifier Type: -
Identifier Source: org_study_id
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