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The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of JAB-21822 following single dose administration with and without a meal
This is an open-label,randomized, 2-cycle,2-period crossover,food effect study. On Day 1 of each period, subjects will receive a single oral dose of JAB-21822 administered either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for JAB-21822 will be collected predose and postdose. There will be a washout period between doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-JAB-21822 | Experimental | Dosing in the fasted state followed by fed dosing |
|
| B-JAB-21822 | Experimental | Dosing in the fed state followed by fasted dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB-21822 | Drug | 2 discrete single doses |
| |
| JAB-21822 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under plasma concentration (AUC) 0 to∞ | Area under the plasma concentration time curve of JAB-21822 | 31days |
| Area under plasma concentration (AUC) 0 to t | Area under the plasma concentration time curve of JAB-21822 | 31days |
| Plasma concentration ( Cmax) | Highest observed plasma concentration of JAB-21822 | 31days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve Cmax (Tmax) | Time of highest observed plasma concentration of JAB-21822 | 31days |
| Elimination rate constant (λz) | Elimination rate constant based on the terminal phase of unchanged form of JAB-21822 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| He Qing B.Pharm | Beijing Gaobo Boren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Boren Hospital | Beijing | Beijing Municipality | 100070 | China |
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This is an open-label,randomized, 2-cycle,2-period crossover,food effect study
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| Drug |
2 discrete single doses |
|
| 31days |
| Concentration half-life (T1/2) | Elimination half-life of unchanged form of JAB-21822 | 31days |
| Absorption lag-time (Tlag) | Elimination lag-time of JAB-21822 | 31days |
| Apparent volume of distribution (Vz/F) | Apparent volume of distribution based on the terminal phase of unchanged form of JAB-21822 | 31days |
| Apparent clearance (CL/F) | Apparent total body clearance of unchanged form of JAB-21822 | 31days |
| Number of participants with adverse events (AEs) and serious adverse events(SAEs) | Incidence,duration and severity of adverse events and serious adverse events according to NCI-CTCAE v5.0 | 31days |
| Number of subjects with abnormal lab parameters | Abnormal values of lab parameters | 31days |
| Number of subjects with abnormal electrocardiogram (12-lead ECG) | Prolongation of the QTc interval | 31days |
| Number of subjects with abnormal systolic and diastolic blood pressure | Abnormal values in systolic and diastolic blood pressure | 31days |
| Number of subjects with abnormal pulse rate | Abnormal values in pulse rate | 31days |
| Number of subjects with abnormal respiratory rate | Abnormal values in respiratory rate | 31days |
| Number of subjects with abnormal body temperature | Abnormal values of body temperature | 31days |