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This is a phase I study to evaluate drug-drug interactions (DDIs) of D-1553 as a perpetrator combined with midazolam (CYP3A4 substrate), caffeine (CYP1A2 substrate), rosuvastatin (OATP1B1/OATP1B3 substrate), furosemide (OAT1/OATP1B3 substrate), and digoxin (P-gp substrate) and to evaluate DDIs of D-1553 as a victim combined with itraconazole (inhibitor of CYP3A4 and P-gp) and omeprazole (proton-pump inhibitor) in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multipledose D-1553 on PK of single dose midazolam, caffeine, rosuvastatin, furosemide, digoxin | Experimental | To evaluate the effects of multiple-dose D-1553 tablets on pharmacokinetics (PK) of single-dose midazolam, caffeine, rosuvastatin, furosemide, and digoxin in healthy male subjects. |
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| Evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553 | Experimental | To evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553 tablets in healthy male subjects. |
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| Evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553 | Experimental | To evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553 tablets in healthy male subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-1553 | Drug | D-1553 is a novel, targeted KRASG12C inhibitor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: maximum concentration (Cmax). | Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin before and after co-administration of D-1553 tablets: maximum concentration (Cmax). | Before and after co-administration of D-1553, approximately day1 and day10 |
| Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: area under the concentration-time curve from the time of dosing to time t (AUC0-t). | Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin before and after co-administration of D-1553 tablets: area under the concentration-time curve from the time of dosing to time t (AUC0-t). | Before and after co-administration of D-1553, approximately day1 and day10 |
| Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: area under the concentration-time curve from time 0 to infinity (AUC0-∞). | Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin before and after co-administration of D-1553 tablets: area under the concentration-time curve from time 0 to infinity (AUC0-∞). | Before and after co-administration of D-1553, approximately day1 and day10 |
| Primary PK parameters of D-1553: maximum concentration (Cmax). | Primary PK parameters of D-1553 before and after co-administration of itraconazole: maximum concentration (Cmax). | Before and after co-administration of itraconazole, approximately day1 and day9 |
| Primary PK parameters of D-1553: area under the concentration-time curve from the time of dosing to time t (AUC0-t). | Primary PK parameters of D-1553 before and after co-administration of itraconazole: area under the concentration-time curve from the time of dosing to time t (AUC0-t). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui District Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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| Before and after co-administration of itraconazole, approximately day1 and day9 |
| Primary PK parameters of D-1553: area under the concentration-time curve from time 0 to infinity (AUC0-∞). | Primary PK parameters of D-1553 before and after co-administration of itraconazole: area under the concentration-time curve from time 0 to infinity (AUC0-∞). | Before and after co-administration of itraconazole, approximately day1 and day9 |
| Primary PK parameters of D-1553: maximum concentration (Cmax). | Primary PK parameters of D-1553 before and after co-administration of omeprazole: maximum concentration (Cmax). | Before and after co-administration of omeprazole, approximately day1 and day8 |
| Primary PK parameters of D-1553: area under the concentration-time curve from the time of dosing to time t (AUC0-t). | Primary PK parameters of D-1553 before and after co-administration of omeprazole: area under the concentration-time curve from the time of dosing to time t (AUC0-t). | Before and after co-administration of omeprazole, approximately day1 and day8 |
| Primary PK parameters of D-1553: area under the concentration-time curve from time 0 to infinity (AUC0-∞). | Primary PK parameters of D-1553 before and after co-administration of omeprazole: area under the concentration-time curve from time 0 to infinity (AUC0-∞). | Before and after co-administration of omeprazole, approximately day1 and day8 |