ABBV-932 for Healthy Subjects

No longer recruiting at 1 trial location

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Illness, Infection, Hospitalization, Surgery, others

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the experimental treatment ABBV-932 behaves in the body, assesses its safety, and evaluates its tolerability. It includes several groups, such as Japanese and Han-Chinese participants, with some receiving the actual treatment and others receiving a placebo (a harmless pill resembling the real treatment). The trial seeks healthy individuals with a BMI between 18.0 and 32.0 who are generally in good health. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the 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.

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

Research has shown that ABBV-932 has been tested in adults to assess its safety and tolerability. In studies with healthy participants, researchers examined reactions to ABBV-932 and identified any side effects. Initial results suggest it is generally well-tolerated, with no serious side effects reported.

In studies involving individuals with bipolar disorder, researchers observed ABBV-932 for safety. Although specific side effects were not listed, these studies typically aim to ensure no unexpected or serious issues arise. Such research helps scientists anticipate outcomes when the treatment is used in larger groups.

As ABBV-932 remains in the early stages of testing, the primary goal is to confirm its safety for further study. More information will be collected as research progresses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ABBV-932 is unique because it targets specific pathways that other treatments for its intended condition do not address, potentially offering a new approach to therapy. While traditional treatments might focus on broad mechanisms, ABBV-932 is designed to hone in on precise biological processes, which could lead to more effective and personalized treatment options. Researchers are excited about ABBV-932 because it may offer improved efficacy and fewer side effects compared to existing options, providing a promising alternative for patients.

What evidence suggests that ABBV-932 could be effective?

Research has shown that ABBV-932 is under investigation as a potential treatment for bipolar I or II disorder, specifically targeting depressive episodes. Early studies suggest it might help reduce symptoms of these episodes. Participants in these studies noticed changes in their condition, indicating some improvement. Although detailed information from human studies remains limited, researchers are closely monitoring the drug for safety and effectiveness. Overall, ABBV-932 appears promising, but further research is necessary to fully understand its effects. ^{1 2 5 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, including Japanese and Han Chinese individuals with a BMI between 18.0 to 32.0 kg/m2. Participants must be in good health based on medical history, physical exams, lab tests, neurological exams, and ECG results. Those who've had significant illness or surgery within the last 30 days cannot join.

Inclusion Criteria

I am a healthy individual of Japanese or Han Chinese descent with a BMI between 18.0 and 30.0.

My overall health is good based on recent medical exams.

I am healthy with a BMI between 18.0 and 32.0.

Exclusion Criteria

I haven't had any serious illnesses, infections, fevers, hospital stays, or surgeries in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABBV-932 or placebo on Day 1 and are followed for pharmacokinetics, safety, and tolerability assessment

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-932
• Placebo

Trial Overview The study is testing ABBV-932 oral capsules to see how they're processed by the body (pharmacokinetics) and to check their safety and tolerability compared to a placebo (a pill without active medication).

How Is the Trial Designed?

Group I: Part 3: Japanese Participants: ABBV-932 Experimental Treatment 1 Intervention

Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days.

Group II: Part 3: Han-Chinese Participants: ABBV-932 Experimental Treatment 1 Intervention

Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.

Group III: Part 2: Sequence 2 Experimental Treatment 1 Intervention

Participants will receive ABBV-932 with food on Day 1 in Period 1 and followed for 30 days. Participants will receive ABBV-932 on Day 1 in Period 2 under fasting conditions and followed for 30 days.

Group IV: Part 2: Sequence 1 Experimental Treatment 1 Intervention

Participants will receive ABBV-932 on Day 1 in Period 1 under fasting conditions and followed for 30 days. Participants will receive ABBV-932 with food on Day 1 in Period 2 and followed for 30 days.

Group V: Part 1: ABBV-932 Experimental Treatment 1 Intervention

Participants will receive ABBV-932 on Day 1 and followed for 30 days.

Group VI: Part 3: Japanese Participants: Placebo Placebo Group 1 Intervention

Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.

Group VII: Part 1: Placebo Placebo Group 1 Intervention

Participants will receive placebo on Day 1 and 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

Gedeon Richter Plc.

Industry Sponsor

Trials

17

Recruited

173,000+

Founded

1901

Headquarters

Budapest, Hungary

Known For

Women's Health Innovations

Top Products

Reagila (cariprazine), Pegfilgrastim (biosimilar), Estelle (contraceptive)

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. 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 ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/533135

Study of Oral ABBV-932 to Assess Adverse Events and ... ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder ...

5. 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 ...

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. Generalized ...