A Phase 1 interventional study of D-1553 in Healthy Male, sponsored by InventisBio Co., Ltd. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by InventisBio Co., Ltd · Phase 1, Interventional, and Other
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.
InventisBio Co., Ltd is the lead sponsor of 32 studies on the registry; 10 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
Drug: D-1553
To evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553 tablets in healthy male subjects.
Drug: D-1553
To evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553 tablets in healthy male subjects.
Drug: D-1553
D-1553 is a novel, targeted KRASG12C inhibitor.
Also known as: other
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).
Time frame: 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).
Time frame: 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-∞).
Time frame: 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).
Time frame: 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).
Time frame: 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-∞).
Time frame: 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).
Time frame: 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).
Time frame: 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-∞).
Time frame: Before and after co-administration of omeprazole, approximately day1 and day8
Plan to share: No
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InventisBio Co., Ltd