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

October 11, 2024 updated by: InventisBio Co., Ltd

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Shanghai Xuhui District Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: D-1553
D-1553 is a novel, targeted KRASG12C inhibitor.
Other Names:
  • other
Experimental: 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.
Drug: D-1553
D-1553 is a novel, targeted KRASG12C inhibitor.
Other Names:
  • other
Experimental: 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.
Drug: D-1553
D-1553 is a novel, targeted KRASG12C inhibitor.
Other Names:
  • other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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).
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).
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 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).
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).
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).
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).
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-∞).
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-∞).
Before and after co-administration of itraconazole, approximately day1 and day9
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).
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).
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).
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-∞).
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-∞).
Before and after co-administration of omeprazole, approximately day1 and day8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InventisBio Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1553-107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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