A Single Dose Study to Assess Adverse Events and How Oral... | NCT06722417

NCT06722417

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Icalcaprant	Drug	Oral capsules	Group 1: Icalcaprant Dose A- Japanese Participants Group 2: Icalcaprant Dose A- Han Chinese Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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.