Drug Interaction Study in Healthy Subjects
(529 DDI ITZ Trial)
AC
Overseen ByABBVIE CALL CENTER
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: AbbVie
No Placebo Group
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
AI
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.
Treatment Details
Interventions
- Icalcaprant (Other)
- Itraconazole (Other)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Icalcaprant with ItraconazoleExperimental Treatment2 Interventions
Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days.
Find a Clinic Near You
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