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Completed

NCT Number: NCT06722417

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

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

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, LLC /ID# 271323

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Icalcaprant

Drug

Oral capsules

Other names: ABBV-1354, CVL-354

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Icalcaprant

    Time frame: Up to approximately 6 days

    Cmax of Icalcaprant

  2. Time to Cmax (Tmax) of Icalcaprant

    Time frame: Up to approximately 6 days

    Tmax of Icalcaprant

  3. Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant

    Time frame: Up to approximately 6 days

    Beta of Icalcaprant

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

    Time frame: Up to approximately 6 days

    T1/2 of Icalcaprant

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

    Time frame: Up to approximately 6 days

    AUCt of Icalcaprant

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

    Time frame: Up to approximately 6 days

    AUCinf of Icalcaprant

  7. Number of Participants with Adverse Events (AEs)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Icalcaprant in Healthy Adult Japanese and Han Chinese Subjects

Acronym: 528 Asian PK

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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