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The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR1459 tablets.
The secondary objective of the study is to evaluate the safety of single dose of SHR1459 orally in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR1459 fasted in P1, high-fat diet in P2 | Drug | SHR1459 administration in fasted condition in period 1, SHR1459 administration after high-fat diet in period 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Cmax of SHR1459 | Peak Plasma Concentration (Cmax) of SHR1459 | through study completion, an average of 23 days |
| Pharmacokinetics parameter: AUC of SHR1459 | Area under the plasma concentration versus time curve (AUC) of SHR1459 | through study completion, an average of 23 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Tmax of SHR1459 | Time of maximum observed concentration (Tmax) of SHR1459 | through study completion, an average of 23 days |
| Pharmacokinetics parameter: T1/2 of SHR1459 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Li, M.D., Ph.D. | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical College | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D059305 | Diet, High-Fat |
| C020845 | P-2 |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| SHR1459 high-fat diet in P1, fasted in P2 | Drug | SHR1459 administration after high-fat diet in period 1, SHR1459 administration in fasted condition in period 2 |
|
Half time (T1/2) of SHR1459
| through study completion, an average of 23 days |
| Pharmacokinetics parameter: CL/F of SHR1459 | Total body clearance for extravascular administration (CL/F) of SHR1459 | through study completion, an average of 23 days |
| Pharmacokinetics parameter: Vz/F of SHR1459 | Volume of distribution (Vz/F) of SHR1459 | through study completion, an average of 23 days |
| Number of patients with Adverse Events (AEs) | To assess the adverse events according to CTCAE5.0 | through study completion, an average of 23 days |
| Vital sign (Blood pressure [BP]) | To assess the vital signs as a criteria of safety and tolerability variables. | through study completion, an average of 23 days |
| Vital sign (pulse) | To assess the vital signs as a criteria of safety and tolerability variables. | through study completion, an average of 23 days |
| Vital sign (temperature) | To assess the vital signs as a criteria of safety and tolerability variables. | through study completion, an average of 23 days |
| Resting and digital electrocardiograms (ECGs) | To assess the cardiovascular system functioning as a criteria of safety and tolerability variables. | through study completion, an average of 23 days |
| Physical examination | To assess the physical conditions as a criteria of safety and tolerability variables. | through study completion, an average of 23 days |
| Laboratory assessments | To assess the hematology, clinical chemistry and urinalysis as a criteria of safety and tolerability variables. | through study completion, an average of 23 days |