Drug Interaction Study in Healthy Subjects

(529 DDI ITZ Trial)

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Allergies, Gastrointestinal conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of icalcaprant in healthy participants.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for healthy adults. Specific details about who can join are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.

I am generally healthy based on recent medical exams and tests.

Exclusion Criteria

I have not taken icalcaprant in the last 90 days.

History of any clinically significant sensitivity or allergy to any medication or food

I have a condition or had surgery that could affect my stomach or intestine's function.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive oral Icalcaprant with Itraconazole for up to 8 days

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• Icalcaprant
• Itraconazole

Trial Overview The study is testing how the drug Icalcaprant behaves in the body when taken with another drug called Itraconazole. Participants will receive a single dose of Icalcaprant to see if there's any change when it's combined with a strong CYP3A inhibitor like Itraconazole.

Participant Groups

Group I: Icalcaprant with Itraconazole Experimental Treatment 2 Interventions

Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois