Icalcaprant for Healthy Subjects

(528 Asian PK Trial)

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Epilepsy, Seizure, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how the body processes, reacts to, and tolerates a new drug called icalcaprant. The study focuses on healthy Japanese and Han Chinese individuals to ensure the treatment's safety for these populations. Participants will take a single oral dose of icalcaprant and undergo monitoring for 30 days. Eligibility may include those who are healthy, follow a traditional Japanese or Chinese lifestyle, and have a BMI (a measure of body fat based on height and weight) between 18 and 32. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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 study is for healthy participants, it's likely that you should not be on any regular medications. Please check with the trial organizers for specific guidance.

Is there any evidence suggesting that icalcaprant is likely to be safe for humans?

Research has shown that icalcaprant, the drug tested in this trial, is generally well-tolerated. Studies have examined its safety in various groups, including individuals with bipolar disorder, and found that most can take the treatment without major problems.

No severe adverse events have been reported with icalcaprant use, suggesting that the treatment usually does not cause serious side effects. As this trial is in the early phase, it primarily focuses on assessing safety and how the body processes the drug. The treatment is still under careful study for any unexpected effects in healthy participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Icalcaprant is unique because it offers a new approach by potentially targeting specific pathways that current treatments for related conditions might not address. While many existing options focus on broad mechanisms, Icalcaprant is designed to provide targeted action, which could lead to more effective and faster results. Researchers are excited about its specific action and the possibility of improved outcomes, particularly for different ethnic groups, which could lead to personalized treatment strategies.

What evidence suggests that icalcaprant could be effective?

This trial will study Icalcaprant in healthy subjects. Studies have shown that Icalcaprant can reduce symptoms in people with bipolar depression. In one study, participants with bipolar disorder experienced improvement in their depression when taking Icalcaprant. Additionally, animal research suggests that Icalcaprant might alleviate withdrawal symptoms from opioids. It blocks certain brain areas involved in mood and reward, which could make it useful for treating mood disorders and addiction. While more research is needed, these findings provide early signs of its potential benefits. ^{1 4 6 7 8}

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 Japanese and Han Chinese individuals. Specific eligibility criteria are not detailed, but typically participants must meet certain health standards and have no conflicting medical conditions.

Inclusion Criteria

Healthy Han Chinese individuals of full Chinese parentage maintaining a typical Chinese lifestyle

BMI is ≥ 18.0 to ≤ 32.0 kg/m^2

Healthy Japanese individuals of full Japanese parentage maintaining a typical Japanese lifestyle

Exclusion Criteria

Tobacco or nicotine-containing product use within 180 days prior to the first dose of study drug

History of allergic reaction or significant sensitivity to study drug constituents or products in the same class

I do not have a history of major health issues like epilepsy, severe head injuries, or uncontrolled illnesses.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of Icalcaprant

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Icalcaprant

Trial Overview

The study is testing Icalcaprant, an oral medication. It aims to understand how the drug moves through the body (pharmacokinetics), its safety, and how well it's tolerated when taken by healthy adults from specific populations.

How Is the Trial Designed?

Group I: Group 2: Icalcaprant Dose A- Han Chinese Participants Experimental Treatment 1 Intervention

Participants will receive oral Icalcaprant dose A once, then a 30-day follow-up period.

Group II: Group 1: Icalcaprant Dose A- Japanese Participants Experimental Treatment 1 Intervention

Participants will receive oral Icalcaprant dose A once, then a 30-day follow-up period.

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/NCT06696755

NCT06696755 | A Study to Assess Adverse Events and ...

This study will assess how safe and effective Icalcaprant is in treating adult participants with bipolar I or II disorder. Icalcaprant is an investigational ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11251157/

Efficacy and safety of aticaprant, a kappa receptor antagonist ...

In this study of participants with MDD and inadequate response to SSRI/SNRI, adjunctive treatment with aticaprant significantly reduced depressive symptoms ...

3.

synapse.patsnap.com

synapse.patsnap.com/drug/fc314c1614d64e1283e1ae43502c5057

CVL 354 - Drug Targets, Indications, Patents

A Phase 2, Multicenter, 6-Week, Double Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects With Bipolar Depression.

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

... (Icalcaprant) in healthy male volunteers. This study tracks how the body processes and eliminates the drug to ensure future safety and efficacy.

5.

withpower.com

withpower.com/trial/phase-1-depressive-disorder-9-2021-0871f

A Single and Multiple Ascending Dose Trial of CVL-354 in ...

Animal studies have shown that CVL-354 can reduce physical signs of withdrawal from opioids, suggesting it could help manage symptoms related to opioid use.

6.

withpower.com

withpower.com/trial/icalcaprant-for-healthy-subjects-706bc

Icalcaprant for Healthy Subjects (528 Asian PK Trial)

This study will assess the pharmacokinetics, safety, and tolerability of icalcaprant administered orally in healthy adult Japanese and Han Chinese participants.

7.

cdek.pharmacy.purdue.edu

cdek.pharmacy.purdue.edu/trial/NCT06722417/

Trial | NCT06722417

This study will assess the pharmacokinetics, safety, and tolerability of icalcaprant administered orally in healthy adult Japanese and Han Chinese participants.

8.

adisinsight.springer.com

adisinsight.springer.com/drugs/800057691

Icalcaprant - Cerevel Therapeutics - AdisInsight - Springer

Icalcaprant (formerly known as CVL 354) is a kappa opiate receptor antagonist (KORA), being developed by Cerevel Therapeutics (a subsidiary of AbbVie), ...