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

Healthy Clinical Trial

Official title:

A Phase 1 Study to Evaluate Safety, Tolerability, and Food-Effect Following Administration of ABBV-CLS-7262 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06145607
• Other study ID #: M24-851
• Status: Completed
• Phase: Phase 1
• Start date: December 19, 2023
• Est. completion date: February 26, 2024

Study information

• Verified date: March 2024
• Source: Calico Life Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 26, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ABBV-CLS-7262
ABBV-CLS-7262

Locations

Country	Name	City	State
United States	AbbVie Clinical Pharmacology Research Unit (ACPRU)	Grayslake	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Calico Life Sciences LLC	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Safety and Tolerability	Number of patients with treatment-related adverse events as assessed by NCI CTCAE v4.03	Approximately Six Weeks