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Completed

NCT Number: NCT06105255

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

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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Key information

Conditions

Healthy Male

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

D-1553

Drug

D-1553 is a novel, targeted KRASG12C inhibitor.

Other names: other

Primary outcomes

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

  2. 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).

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

    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).

  3. 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 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-∞).

  4. Primary PK parameters of D-1553: maximum concentration (Cmax).

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

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

  5. Primary PK parameters of D-1553: 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

    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).

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

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

    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-∞).

  7. Primary PK parameters of D-1553: maximum concentration (Cmax).

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

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

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

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

    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).

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

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

    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-∞).

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 27, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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