Healthy Male
Conditions
Brief summary
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.
Interventions
DRUGD-1553
D-1553 is a novel, targeted KRASG12C inhibitor.
Sponsors
InventisBio Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who volunteer to participate in this clinical trial, understand the study procedures and sign the Informed Consent Form (ICF) in writing. * Male, aged 18-45 years (both inclusive) at the time of signing the ICF. * Non-smokers or subjects who smoked no more than 5 cigarettes or 1 pipe per day within 3 months prior to screening.
Exclusion criteria
* Subjects with any clinically significant acute diseases as judged by the investigators within one month prior to screening. * Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody. * Subjects with a history of blood or needle phobia. * Subjects with a history of hypersensitivity to the investigational drug and/or any preparation ingredients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: 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 before and after co-administration of D-1553 tablets: maximum concentration (Cmax). |
| 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). | Before and after co-administration of D-1553, approximately day1 and day10 | 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). |
| Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: 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 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-∞). |
| Primary PK parameters of D-1553: maximum concentration (Cmax). | Before and after co-administration of itraconazole, approximately day1 and day9 | Primary PK parameters of D-1553 before and after co-administration of itraconazole: maximum concentration (Cmax). |
| Primary PK parameters of D-1553: area under the concentration-time curve from the time of dosing to time t (AUC0-t). | Before and after co-administration of itraconazole, approximately day1 and day9 | 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). |
| Primary PK parameters of D-1553: 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 before and after co-administration of itraconazole: area under the concentration-time curve from time 0 to infinity (AUC0-∞). |
Countries
China
Outcome results
None listed