Status:
COMPLETED
A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262
Lead Sponsor:
Calico Life Sciences LLC
Collaborating Sponsors:
AbbVie
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects.
Detailed Description
On Day 1 of each period, subjects will receive a single oral dose of ABBV-CLS-7262 administered according to the food regimen assigned. There will be a 4-day washout period between doses. Food regimen...
Eligibility Criteria
Inclusion
- 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 ≤ 32.0 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
- 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
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06145607
Start Date
December 19 2023
End Date
February 26 2024
Last Update
March 8 2024
Active Locations (1)
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1
AbbVie Clinical Pharmacology Research Unit (ACPRU)
Grayslake, Illinois, United States, 60030