A Single Dose Study to Assess Adverse Events and How Oral Icalcaprant Moves Through the Body in Healthy Adult Japanese and Han Chinese Participants

Phase 1

Recruiting

• Conditions: Healthy Volunteer
• Interventions: Drug: Icalcaprant

• Registration Number: NCT06722417
• Lead Sponsor: AbbVie

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-02
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Healthy Japanese or Han Chinese individuals.
• Japanese participants must be first or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
• Han Chinese participants must be first or second-generation Han Chinese of full Chinese parentage. First-generation participants will have been born in China to two parents and four grandparents also born in China of full Han Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Han Chinese descent. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
• Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

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Exclusion Criteria

• History of epilepsy, seizure (except febrile seizure during childhood), unexplained alteration of consciousness, head injury with associated loss of consciousness, sleep disorder (except mild insomnia not requiring daily therapy), any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. - History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
• No use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
• History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Icalcaprant Dose A- Japanese Participants	Icalcaprant	Participants will receive oral Icalcaprant dose A once, then a 30-day follow-up period.
Group 2: Icalcaprant Dose A- Han Chinese Participants	Icalcaprant	Participants will receive oral Icalcaprant dose A once, then a 30-day follow-up period.

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of Icalcaprant	Up to approximately 6 days	Cmax of Icalcaprant
Time to Cmax (Tmax) of Icalcaprant	Up to approximately 6 days	Tmax of Icalcaprant
Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant	Up to approximately 6 days	Beta of Icalcaprant
Terminal Phase Elimination Half-Life (t1/2) of Icalcaprant	Up to approximately 6 days	T1/2 of Icalcaprant
Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant	Up to approximately 6 days	AUCt of Icalcaprant
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant	Up to approximately 6 days	AUCinf of Icalcaprant
Number of Participants with Adverse Events (AEs)	Up to approximately 37 days	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study

Trial Locations

Locations (1)

Anaheim Clinical Trials, LLC /ID# 271323; 🇺🇸 Anaheim, California, United States