Clinical trial 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
Official title: An Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Icalcaprant in Healthy Adult Japanese and Han Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
Icalcaprant
ABBV-1354
CVL-354
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-12-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Icalcaprant
timeFrame: Up to approximately 6 days
measure: Time to Cmax (Tmax) of Icalcaprant
timeFrame: Up to approximately 6 days
measure: Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant
timeFrame: Up to approximately 6 days
measure: Terminal Phase Elimination Half-Life (t1/2) of Icalcaprant
timeFrame: Up to approximately 6 days
measure: Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant
timeFrame: Up to approximately 6 days
measure: Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant
timeFrame: Up to approximately 6 days
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 37 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC /ID# 271323
state: California
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: