ABBV-1354 for Healthy Subjects

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Male

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: Unknown

Duration: 1 day

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ABBV-1354, an oral treatment, to understand its processing in healthy male bodies. The focus is on tracking the drug's movement and breakdown over time. Men who are generally healthy, with no major medical conditions, and meet certain lifestyle criteria are suitable candidates. Participants must adhere to specific contraceptive guidelines during and after the trial. 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 taking my current medications for 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 or your doctor.

Is there any evidence suggesting that ABBV-1354 is likely to be safe for humans?

Research shows that ABBV-1354 is being tested in healthy adults to assess its safety. In this early stage of testing, the main goal is to determine if the drug is safe and well-tolerated. Previous studies lack specific details on side effects for ABBV-1354, so information on that is limited.

However, early-stage trials like this one involve careful monitoring to ensure participant safety. Testing ABBV-1354 in healthy individuals means researchers are still learning about its basic safety. They are evaluating how the body processes the drug and identifying any potential side effects. Participants receive close monitoring to quickly identify any possible risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ABBV-1354 is unique because it introduces a new approach by delivering treatment through a single oral dose, which is different from the more common, ongoing treatment regimens. Most current treatments rely on mechanisms that address symptoms over a prolonged period, but ABBV-1354's design might allow for quicker intervention. Researchers are particularly excited about its potential to streamline treatment and improve patient compliance due to its simplified dosing.

What evidence suggests that ABBV-1354 could be effective?

Research shows that ABBV-1354, also known as Icalcaprant, is a new treatment tested in healthy individuals in this trial. The trial primarily focuses on understanding how the body processes the drug, including its absorption, distribution, metabolism, and excretion. Although ABBV-1354 remains in the early stages of research, scientists closely examine its mechanisms. The goal is for ongoing studies to reveal more about its potential benefits and applications. ^{1 2 3 4 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for healthy adult men who are interested in helping to understand how a new drug, ABBV-1354, behaves in the body. There aren't specific inclusion or exclusion criteria provided, but typically participants should not have any significant health issues.

Inclusion Criteria

I will ensure my partner uses effective birth control if she can have children.

BMI must be ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening

I am in good health overall, as confirmed by recent medical exams.

Exclusion Criteria

I do not have any significant ongoing health issues besides my current condition.

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

I do not have conditions or surgeries that affect my stomach or intestines.

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 oral ABBV-1354

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-1354

Trial Overview The study focuses on assessing the mass balance of ABBV-1354 when taken orally by healthy male volunteers. This will help determine how the drug is absorbed, distributed, metabolized, and excreted from the body.

How Is the Trial Designed?

Group I: ABBV-1354 Experimental Treatment 1 Intervention

Participants will receive a single dose of oral ABBV-1354 and followed 30 days post dose.

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/NCT07219017

A Study to Assess the Mass Balance of Oral ABBV-1354 in ... This study is to assess the mass balance of oral ABBV-1354 in healthy adult male participants. Official Title. Mass Balance Study of [14C] ABBV- ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-9-2025-1bac4

ABBV-1354 for Healthy Subjects This Phase 1 medical study run by AbbVie is evaluating whether ABBV-1354 will have tolerable side effects & efficacy for patients with Healthy Subjects.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06696755

NCT06696755 | A Study to Assess Adverse Events and ... Participants will receive oral Icalcaprant dose A once daily for 6 weeks and followed for 4 weeks. Other Names: ABBV-1354. CVL-354.

4. ichgcp.net ichgcp.net/clinical-trials-registry/556308-a-study-to-assess-the-mass-balance-of-oral-abbv-1354-in-healthy-adult-male-participants

A Phase 1 Study in Healthy Volunteers - Clinical Trials Registry Learn about a Phase 1 mass balance study for the investigational drug ABBV-1354 (Icalcaprant) in healthy male volunteers.

5. adisinsight.springer.com adisinsight.springer.com/trials/700387308

Mass Balance Study of [14C] ABBV-1354 (Icalcaprant) in ... This study is to assess the mass balance of oral ABBV-1354 in healthy adult male participants.

6. abbvie.com abbvie.com/science/pipeline.html

Pipeline Pipeline: Advanced medicines that demonstrate both strong clinical performance and benefits to patients.