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

NCT06105255 | Completed Phase 1 FDA Drug

• 1 other identifier: D1553-107
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Male

Outcome Measures

Primary Outcomes (9)

• 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 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 PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: area under the concentration-time curve from time 0 to infinity (AUC0-∞).

  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-∞).

  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).

  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).

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

• Primary PK parameters of D-1553: area under the concentration-time curve from time 0 to infinity (AUC0-∞).

  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-∞).

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

• 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 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 PK parameters of D-1553: area under the concentration-time curve from time 0 to infinity (AUC0-∞).

  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-∞).

  Before and after co-administration of omeprazole, approximately day1 and day8

Study Arms (3)

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

EXPERIMENTAL

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.

Drug: D-1553

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

EXPERIMENTAL

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

Drug: D-1553

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

EXPERIMENTAL

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

Drug: D-1553

Interventions

D-1553 DRUG

D-1553 is a novel, targeted KRASG12C inhibitor.

Also known as: other

Evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553; Evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553; Multipledose D-1553 on PK of single dose midazolam, caffeine, rosuvastatin, furosemide, digoxin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (1)

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 27, 2023
• Study Start: May 24, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)