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

Healthy Male Clinical Trial

Official title:

A Phase I Study to Evaluate the Effects of Multiple-dose D-1553 on Pharmacokinetics of Single-dose Midazolam, Caffeine, Rosuvastatin, Furosemide and Digoxin, and to Evaluate the Effects of Multiple-dose Itraconazole and Omeprazole on Pharmacokinetics of Single-dose D-1553 in Healthy Male Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06105255
• Other study ID #: D1553-107
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 24, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: InventisBio Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: July 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Male

Intervention

Drug:
• D-1553
D-1553 is a novel, targeted KRASG12C inhibitor.

Locations

Country	Name	City	State
China	Shanghai Xuhui District Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
InventisBio Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Before and after co-administration of D-1553, approximately day1 and day10
Primary	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).	Before and after co-administration of D-1553, approximately day1 and day10
Primary	Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: area under the concentration-time curve from time 0 to infinity (AUC0-8).	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 (AUC0-8).	Before and after co-administration of D-1553, approximately day1 and day10
Primary	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).	Before and after co-administration of itraconazole, approximately day1 and day9
Primary	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).	Before and after co-administration of itraconazole, approximately day1 and day9
Primary	Primary PK parameters of D-1553: area under the concentration-time curve from time 0 to infinity (AUC0-8).	Primary PK parameters of D-1553 before and after co-administration of itraconazole: area under the concentration-time curve from time 0 to infinity (AUC0-8).	Before and after co-administration of itraconazole, approximately day1 and day9
Primary	Primary PK parameters of D-1553: maximum concentration (Cmax).	Primary PK parameters of D-1553 before and after co-administration of omeprazole: maximum concentration (Cmax).	Before and after co-administration of omeprazole, approximately day1 and day8
Primary	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 omeprazole: 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	Primary PK parameters of D-1553: area under the concentration-time curve from time 0 to infinity (AUC0-8).	Primary PK parameters of D-1553 before and after co-administration of omeprazole: area under the concentration-time curve from time 0 to infinity (AUC0-8).	Before and after co-administration of omeprazole, approximately day1 and day8