ABBV-932 + Itraconazole for Healthy Subjects

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Epilepsy, Cardiac, Respiratory, Psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the new drug ABBV-932 behaves in the body when combined with Itraconazole, an antifungal medication. The main goal is to identify any side effects and understand how the body processes these drugs together. It is suitable for individuals in good health without major illnesses or a recent history of mental health issues. Participants will first take ABBV-932 alone, followed by a combination with Itraconazole. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research is examining the safety and mechanism of ABBV-932, particularly when combined with Itraconazole. In earlier studies where ABBV-932 was administered alone, researchers assessed its safety in healthy individuals, monitoring side effects and tolerance.

As this trial is in its early stages, it primarily focuses on safety issues. Consequently, detailed information about the tolerance of ABBV-932 when combined with Itraconazole is limited. However, reaching this stage indicates that ABBV-932 demonstrated sufficient safety potential in initial studies to proceed.

Itraconazole, a well-known medication for treating fungal infections, has a well-documented safety profile. This study aims to understand how ABBV-932 interacts with and is processed in the body when used alongside Itraconazole. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-932 combined with Itraconazole because this duo could offer a novel approach to treatment. Unlike traditional treatments that typically focus on a single target, ABBV-932 works by potentially enhancing the effects of Itraconazole. This combination may provide a more effective way to tackle the underlying issue by leveraging the unique properties of both drugs. The anticipation is that this could lead to improved outcomes compared to existing treatment options.

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

Research is investigating the safety and effectiveness of ABBV-932 for treating bipolar I or II disorder. Earlier studies have examined the drug's mechanism in the body and its potential benefits. This trial tests ABBV-932 in combination with another drug, Itraconazole, to assess their interaction. Detailed results on the effectiveness of ABBV-932 with Itraconazole are not yet available, but these studies are crucial for understanding the drug's effects. Early results suggest that ABBV-932 may hold promise for conditions like bipolar disorder. ^{1 3 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This clinical trial is for healthy adults. Specific eligibility criteria are not provided, but typically participants should have no significant health issues and be willing to follow the study procedures.

Inclusion Criteria

Body Mass Index (BMI) must be ≥ 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.

A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion Criteria

History of epilepsy

History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any 'yes' answer to questions on the Columbia - Suicide Severity Rating Scale (C-SSRS)

I do not have any significant ongoing health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive ABBV-932

Up to approximately 29 days

Treatment Period 2

Participants receive Itraconazole in combination with ABBV-932

Up to approximately 29 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 32 days

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-932
• Itraconazole

Trial Overview The trial is testing how ABBV-932 behaves in the body when taken with Itraconazole. It will look at any adverse events (side effects) and track how ABBV-932 is absorbed, distributed, metabolized, and excreted.

How Is the Trial Designed?

Group I: ABBV-932 with Itraconazole Experimental Treatment 2 Interventions

Participants will receive ABBV-932 in Period 1 followed by Itraconalzole in combination with ABBV-932 in Period 2.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT07071532

A Study to Assess Adverse Events and How Oral ABBV- ... This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in healthy Adults participants.

2. adisinsight.springer.com adisinsight.springer.com/trials/700384365

A Phase 1 Study to Evaluate the Effect of Itraconazole on the ... This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in healthy Adults

3. tipranks.com tipranks.com/news/company-announcements/abbvies-latest-clinical-study-exploring-abbv-932s-pharmacokinetics-with-itraconazole

AbbVie's Latest Clinical Study: Exploring ABBV-932's ... ' The study aims to assess adverse events and how the oral drug ABBV-932 moves through the body when administered with oral Itraconazole in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06605599

NCT06605599 | Study of Oral ABBV-932 to Assess ... This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II disorder.

5. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M23-894

Study of Oral ABBV-932 to Assess Adverse Events and ... This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II disorder.

6. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-6-2025-c2d25

ABBV-932 + Itraconazole for Healthy Subjects This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in healthy Adults participants. Show ...

7. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M23-893

A Study to Evaluate the Pharmacokinetics, Safety, and ... The purpose of this study is to assess the pharmacokinetics, safety, and tolerability following multiple ascending oral doses of ABBV-932 or placebo in healthy ...