Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, Icalcaprant, ABBV-1354, CVL-354
Brief summary
This study will assess the pharmacokinetics, safety, and tolerability of icalcaprant administered orally in healthy adult Japanese and Han Chinese participants.
Interventions
DRUGIcalcaprant
Oral capsules
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed