A Study to Evaluate the Effects of D-1553 on PK of Midazolam, Caffeine, Rosuvastatin, Furosemide, Digoxin, and Itraconazole or Omeprazole on PK of D-1553

Phase 1

Completed

• Conditions: Healthy Male
• Interventions: Drug: D-1553

• Registration Number: NCT06105255
• Lead Sponsor: InventisBio Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-24
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Primary Completion: 2024-02-02
• Study Completion: 2024-02-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multipledose D-1553 on PK of single dose midazolam, caffeine, rosuvastatin, furosemide, digoxin	D-1553	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.
Evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553	D-1553	To evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553 tablets in healthy male subjects.
Evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553	D-1553	To evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553 tablets in healthy male subjects.

Primary Outcome Measures

Name	Time	Method
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 D-1553: 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 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).	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 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-∞).	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-∞).

Trial Locations

Locations (1)

Shanghai Xuhui District Central Hospital; 🇨🇳 Shanghai, Shanghai, China