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

InventisBio

Status and phase: Completed; Phase 1

Conditions: Healthy Male

Treatments: Drug: D-1553

Study type: Interventional

Funder types: Industry

Identifiers

NCT06105255

D1553-107

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Multipledose D-1553 on PK of single dose midazolam, caffeine, rosuvastatin, furosemide, digoxin

Experimental group

Description:

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.

Treatment:

Drug: D-1553

Evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553

Experimental group

Description:

To evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553 tablets in healthy male subjects.

Treatment:

Drug: D-1553

Evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553

Experimental group

Description:

To evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553 tablets in healthy male subjects.

Treatment:

Drug: D-1553