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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ABBV-CLS-7262

• Registration Number: NCT06145607
• Lead Sponsor: Calico Life Sciences LLC

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 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.

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Study Start: 2023-12-19
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Period 1, 2 and 3 ABBV-CLS-7262	ABBV-CLS-7262	* 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.

Primary Outcome Measures

Name	Time	Method
To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food.	Approximately Two Weeks	Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC)
To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce.	Approximately Two Weeks	Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC)

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	Approximately Six Weeks	Number of patients with treatment-related adverse events as assessed by NCI CTCAE v4.03

Trial Locations

Locations (1)

AbbVie Clinical Pharmacology Research Unit (ACPRU); 🇺🇸 Grayslake, Illinois, United States