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

NCT06145607 | Completed Phase 1 FDA Drug

• 1 other identifier: M24-851
• Study Type: interventional
• Actual enrollment (reported): 18
• Locations: 1 country
• Sites: 1
• Actual (reported): Study Start
• Actual (reported): Primary Completion
• Actual (reported): Study Completion

Brief Summary

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

Conditions

Healthy

Keywords

Food effect; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food.

  Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC)

  Approximately Two Weeks

• To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce.

  Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC)

  Approximately Two Weeks

Secondary Outcomes (1)

• Safety and Tolerability

  Approximately Six Weeks

Study Arms (1)

Period 1, 2 and 3 ABBV-CLS-7262

EXPERIMENTAL

* 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.

Drug: ABBV-CLS-7262

Interventions

ABBV-CLS-7262 DRUG

ABBV-CLS-7262

Period 1, 2 and 3 ABBV-CLS-7262

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 ≤ 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.

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

Sponsors & Collaborators

• Calico Life Sciences LLC: lead
• AbbVie: collaborator

Study Sites (1)

AbbVie Clinical Pharmacology Research Unit (ACPRU)

Grayslake, Illinois, 60030, United States

Location

Enrollment

18 participants — actual enrollment reported by the registry.

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Last Updated: March 8, 2024

Study Start

December 19, 2023

Actual (reported)

Primary Completion

January 30, 2024

Actual (reported)

Study Completion

February 26, 2024

Actual (reported)

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)