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This drug-drug interaction (DDI) study had been designed to investigate the effect of a strong CYP 3A index fan-inducer rifampicin on the pharmacokinetics of SHR1459 in Chinese healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifampicin 600 mg + SHR1459 Tablets 200 mg | Experimental |
| |
| SHR1459 tablets 200 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifampin | Drug | single oral dose, 600 mg, fasted. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) for SHR1459. | predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9 | |
| Area Under the Plasma Concentration-time Curve from 0 to any time before the last quantifiable concentration (AUC0-t) for SHR1459. | predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9 | |
| Area Under the Plasma Concentration-time Curve from 0 to infinite time (AUCinf) for SHR1459. | predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9 |
| Measure | Description | Time Frame |
|---|---|---|
| Other pharmacokinetics parameters of SHR1459: Tmax, T1/2, CL, Vd, etc | predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h for Day1 and Day9 | |
| The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0): Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination, vital signs, etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | Shanghai | Shanghai Municipality | 201203 | China |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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To observe the effect of rifampicin on the pharmacokinetics of SHR1459 and to evaluate the safety of SHR1459, rifampicin and their coadministration in Chinese healthy subjects. The subjects will take SHR1459 at first single dose, then washout period, and take it at second single dose after multiple administration of rifampicin to get a full induction condition.
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| SHR1459 |
| Drug |
single oral dose, 200 mg, fasted. |
|
| Baseline up to 14 days post last dose, up to approximately 2 month |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |