A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262

Calico Life Sciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ABBV-CLS-7262

Study type: Interventional

Funder types: Industry

Identifiers

NCT06145607

M24-851

Details and patient eligibility

About

This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects.

Full 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 regimens include administration after fasting, following a high-fat/high-calorie meal, or with apple sauce. Upon completion each subject will have taken a total of three doses of ABBV-CLS-7262, with one dose administered with each food regimen.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 ≤ 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Period 1, 2 and 3 ABBV-CLS-7262

Experimental group

Description:

* Participants will receive ABBV-CLS-7262 administered under fasted conditions. * Participants will receive ABBV-CLS-7262 administered under fed conditions (high-fat/high-calorie breakfast). * Participants will receive ABBV-CLS-7262 administered with applesauce.

Treatment:

Drug: ABBV-CLS-7262