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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how itraconazole, an antifungal medication, affects icalcaprant in healthy individuals. The main goal is to determine how the body processes (absorbs, breaks down, and eliminates) icalcaprant when combined with itraconazole, while also assessing its safety and tolerability. Participants will take both drugs for up to 8 days and then undergo monitoring for 30 days. This trial suits individuals in good health who have not used icalcaprant in the past 90 days. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, since this study involves drug interactions, it's possible that some medications might need to be paused. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that icalcaprant and itraconazole are being studied to assess their safety when used together. Itraconazole already presents some safety concerns on its own. Common side effects include nausea, mild diarrhea, vomiting, and stomach pain. More serious issues, such as heart failure, can occur, particularly in certain individuals.

When combined with other drugs, itraconazole can increase their concentration in the blood, raising the risk of side effects. Understanding how itraconazole might affect icalcaprant when used together is crucial.

This study is in an early phase, so limited safety information is available for icalcaprant. The main goal is to determine how well icalcaprant is tolerated when combined with itraconazole. Participants will assist researchers in identifying any potential safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Icalcaprant, used with Itraconazole, is unique because it explores a potential new interaction between these two drugs. Researchers are excited because Icalcaprant may offer a fresh approach to treatment by working with Itraconazole to optimize drug absorption and effectiveness. This combination could potentially improve outcomes by enhancing how Icalcaprant is metabolized in the body, setting it apart from existing treatments that don't utilize this interaction.

What evidence suggests that this trial's treatments could be effective?

Research is examining how icalcaprant interacts with itraconazole, a potent drug that influences the processing of other drugs in the body. In this trial, participants will take oral icalcaprant with itraconazole to determine the effects on icalcaprant when combined. Currently, limited information exists on icalcaprant's effectiveness for specific health issues, as studies primarily focus on the drug's movement through the body and its safety. Early results mainly address the interaction between these two drugs, not the treatment of any particular health condition. Therefore, solid proof of icalcaprant's effectiveness for specific conditions is not yet available. ^{6 7 8 9 10}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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

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

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M25-529

A Study to Assess Change in How Oral Icalcaprant ... This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-10-2024-3916e

Drug Interaction Study in Healthy Subjects (529 DDI ITZ 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 ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-to-assess-change-in-how-oral-icalcaprant-with-itraconazole-moves-through-the-body-in-healthy

A Study to Assess Change in How Oral Icalcaprant With ... This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40066762/

Drug-drug interaction study with itraconazole ... This study aims to evaluate effect of CYP3A inhibition (using itraconazole) on venglustat exposure and to develop and validate a physiologically based ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02790671

NCT02790671 No information is available for this page.

6. drugs.com drugs.com/sfx/itraconazole-side-effects.html

Itraconazole Side Effects: Common, Severe, Long Term Itraconazole can cause or exacerbate congestive heart failure (CHF). When itraconazole was administered intravenously to healthy human volunteers and dogs, ...

7. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f9d8b5a7-435f-40e6-8596-5f2376b92c74&type=display

ITRACONAZOLE CAPSULES Rx Only See PRECAUTIONS: Drug Interactions Section for specific examples. Coadministration with itraconazole can cause elevated plasma concentrations of these drugs and ...

8. go.drugbank.com go.drugbank.com/drugs/DB01167

Itraconazole: Uses, Interactions, Mechanism of Action The risk or severity of adverse effects can be increased when Itraconazole is combined with Fexinidazole. Fexofenadine, The serum concentration of ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2010/022484s000lbl.pdf

1 This label may not be the latest approved by FDA. For ... WARNING: CONGESTIVE HEART FAILURE, CARDIAC. EFFECTS AND DRUG INTERACTIONS. See full prescribing information for complete boxed warning.

10. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557874/

Itraconazole - StatPearls - NCBI Bookshelf - NIH The most common adverse effects are gastrointestinal disturbances, such as nausea, mild diarrhea, vomiting, and abdominal pain. Researchers noted these side ...