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

NCT06722417 | Completed Phase 1

• 1 other identifier: M25-528
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; Icalcaprant; ABBV-1354; CVL-354

Outcome Measures

Primary Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax) of Icalcaprant

  Cmax of Icalcaprant

  Up to approximately 6 days

• Time to Cmax (Tmax) of Icalcaprant

  Tmax of Icalcaprant

  Up to approximately 6 days

• Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant

  Beta of Icalcaprant

  Up to approximately 6 days

• Terminal Phase Elimination Half-Life (t1/2) of Icalcaprant

  T1/2 of Icalcaprant

  Up to approximately 6 days

• Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant

  AUCt of Icalcaprant

  Up to approximately 6 days

• Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant

  AUCinf of Icalcaprant

  Up to approximately 6 days

• Number of Participants with Adverse Events (AEs)

  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

  Up to approximately 37 days

Study Arms (2)

Group 1: Icalcaprant Dose A- Japanese Participants

EXPERIMENTAL

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

Drug: Icalcaprant

Group 2: Icalcaprant Dose A- Han Chinese Participants

EXPERIMENTAL

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

Drug: Icalcaprant

Interventions

Icalcaprant DRUG

Oral capsules

Also known as: ABBV-1354, CVL-354

Group 1: Icalcaprant Dose A- Japanese Participants; Group 2: Icalcaprant Dose A- Han Chinese Participants

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Anaheim Clinical Trials, LLC /ID# 271323

Anaheim, California, 92801, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: November 26, 2024
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)