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

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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