ABBV-932 for Healthy Subjects

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Epilepsy, Cardiac, Respiratory, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called ABBV-932 to determine how much of the drug enters the bloodstream and whether food affects this process. Healthy adults will receive a single dose, with some taking it alongside a high-fat meal to assess the impact on absorption. Individuals who are generally healthy and free of significant medical conditions may be suitable for this trial. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in humans.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy subjects, it's possible that participants should not be on any regular medications.

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

Research has shown that ABBV-932 has undergone testing in several studies, primarily assessing its safety and tolerability in both healthy individuals and those with mood disorders such as bipolar disorder. One study focused on healthy adults and found that ABBV-932 was generally well-tolerated, with no serious side effects reported. Some participants experienced mild to moderate side effects, but these were not severe enough to halt the study. Common side effects included headaches and mild stomach issues. Overall, current evidence suggests that ABBV-932 is relatively safe for humans, with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about ABBV-932 because it explores different conditions under which a single dose can be effective, particularly focusing on fasting versus high-fat meal conditions. While most treatments for various conditions typically focus on dosage or frequency, ABBV-932 is unique in its approach to understanding how food intake impacts its efficacy. This could lead to more flexible and tailored treatment plans for patients, adapting to their lifestyle and improving convenience without sacrificing effectiveness.

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

Research has shown that ABBV-932 might assist with mental health issues like bipolar disorder, depression, and generalized anxiety disorder (GAD). Studies suggest it can improve symptoms when combined with regular antidepressants. For bipolar disorder, researchers have tested ABBV-932 for safety and effectiveness, yielding some promising results. Early findings indicate it might help manage depression, making it a potentially useful treatment. Although more research is needed, these initial results highlight its potential in addressing these mental health challenges.

In this trial, participants will receive a single dose of ABBV-932 under different conditions, such as fasting or with a high-fat meal, across various treatment arms. ^{1 2 3 6 7}

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 who can safely take the experimental medication ABBV-932. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Body Mass Index (BMI) must be ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.

My overall health is good based on recent medical exams.

Exclusion Criteria

I don't have any serious health issues apart from my current condition.

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

I have a history of epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of ABBV-932 under fasting or fed conditions

1 day

1 visit (in-person)

Pharmacokinetic Assessment

Assessment of the relative bioavailability and effect of food on pharmacokinetics of ABBV-932

6 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

180 days

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-932

Trial Overview The study is testing ABBV-932, an oral medication. It aims to understand how the body absorbs it (bioavailability) and how food affects its absorption (pharmacokinetics).

How Is the Trial Designed?

Group I: ABBV-932: Arm G-Optional Experimental Treatment 1 Intervention

Participants will receive a single dose of ABBV-932 Arm G on day 1 with a high-fat meal.

Group II: ABBV-932: Arm F-Optional Experimental Treatment 1 Intervention

Participants will receive a single dose of ABBV-932 Arm F on day 1 under fasting conditions.

Group III: ABBV-932: Arm E Experimental Treatment 1 Intervention

Participants will receive a single dose of ABBV-932 Arm E on day 1 with a high-fat meal.

Group IV: ABBV-932: Arm D Experimental Treatment 1 Intervention

Participants will receive a single dose of ABBV-932 Arm D on day 1 with a high-fat meal.

Group V: ABBV-932: Arm C Experimental Treatment 1 Intervention

Participants will receive a single dose of ABBV-932 Arm C on day 1 under fasting conditions.

Group VI: ABBV-932: Arm B Experimental Treatment 1 Intervention

Participants will receive a single dose of ABBV-932 Arm B on day 1 under fasting conditions.

Group VII: ABBV-932: Arm A Experimental Treatment 1 Intervention

Participants will receive a single dose of ABBV-932 Arm A on day 1 under fasting conditions.

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/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. ABBV-932 is an investigational drug being ...

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

Study of Oral ABBV-932 to Assess Adverse Events and ... Study of oral ABBV-932 to assess adverse events and change in disease activity in adult participants with Bipolar I or II disorder.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07220460

Study to Assess the Adverse Events of Oral ABBV-932 in ... The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated with ...

4. ctv.veeva.com ctv.veeva.com/study/study-to-assess-the-adverse-events-of-oral-abbv-932-in-adult-participants-with-depressive-episodes-a

Study to Assess the Adverse Events of Oral ABBV-932 in Adult ... The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated with ...

5. withpower.com withpower.com/trial/abbv-932-for-generalized-anxiety-disorder-fdc2b

ABBV-932 for Generalized Anxiety Disorder Research shows that ABBV-932 might enhance the effects of standard antidepressant treatments for generalized anxiety disorder (GAD). Earlier studies examined ...

6. 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05738850?cond=GAD&aggFilters=status:&viewType=Table&rank=6

Study to Assess Adverse Events and How ABBV-932 Oral ... The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants. Official Title.