Status:
COMPLETED
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
Lead Sponsor:
InventisBio Co., Ltd
Conditions:
Healthy Male
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 subs...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06105255
Start Date
May 24 2023
End Date
February 2 2024
Last Update
October 15 2024
Active Locations (1)
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1
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, China, 200031