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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2024-02-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Male

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

D-1553

Intervention Type DRUG

D-1553 is a novel, targeted KRASG12C inhibitor.

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.

Group Type EXPERIMENTAL

D-1553

Intervention Type DRUG

D-1553 is a novel, targeted KRASG12C inhibitor.

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.

Group Type EXPERIMENTAL

D-1553

Intervention Type DRUG

D-1553 is a novel, targeted KRASG12C inhibitor.

Interventions

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D-1553

D-1553 is a novel, targeted KRASG12C inhibitor.

Intervention Type DRUG

Other Intervention Names

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other

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes