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

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Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Male

Interventions

D-1553DRUG

D-1553 is a novel, targeted KRASG12C inhibitor.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: maximum concentration (Cmax).

Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin before and after co-administration of D-1553 tablets: 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: 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 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).

Time frame: Before and after co-administration of D-1553, approximately day1 and day10

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 D-1553: maximum concentration (Cmax).

Primary PK parameters of D-1553 before and after co-administration of itraconazole: maximum concentration (Cmax).

Time frame: Before and after co-administration of itraconazole, approximately day1 and day9

Primary PK parameters of D-1553: area under the concentration-time curve from the time of dosing to time t (AUC0-t).

Primary PK parameters of D-1553 before and after co-administration of itraconazole: area under the concentration-time curve from the time of dosing to time t (AUC0-t).

Time frame: Before and after co-administration of itraconazole, approximately day1 and day9

Data from ClinicalTrials.gov

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