A Phase I Study to Evaluate the Effects of Multiple-dose D-1553 on Pharmacokinetics of Single-dose Midazolam, Caffeine, Rosuvastatin, Furosemide and Digoxin, and to Evaluate the Effects of Multiple-dose Itraconazole and Omeprazole on Pharmacokinetics of Single-dose D-1553 in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- D-1553
- Conditions
- Healthy Male
- Sponsor
- InventisBio Co., Ltd
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: maximum concentration (Cmax).
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Multipledose D-1553 on PK of single dose midazolam, caffeine, rosuvastatin, furosemide, digoxin
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.
Intervention: D-1553
Evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553
To evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553 tablets in healthy male subjects.
Intervention: D-1553
Evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553
To evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553 tablets in healthy male subjects.
Intervention: D-1553
Outcomes
Primary Outcomes
Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: 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 before and after co-administration of D-1553 tablets: 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).
Time Frame: Before and after co-administration of omeprazole, approximately day1 and day8
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).
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).
Time Frame: 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-∞).
Time Frame: 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).
Time Frame: Before and after co-administration of omeprazole, approximately day1 and day8
Primary PK parameters of D-1553 before and after co-administration of omeprazole: maximum concentration (Cmax).
Primary PK parameters of D-1553: 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
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-∞).