Healthy MalePhase 1NCT06105255
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
A Phase 1 study testing D-1553 in people with Healthy Male, run by InventisBio Co., Ltd at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male
- What is being tested?
- D-1553
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2023to 2 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
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
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
- Being tested
- D-1553
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-1553Drug
Also called other
D-1553 is a novel, targeted KRASG12C inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: D-1553 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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-∞).
Measured: 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).
Measured: 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).
Measured: 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-∞).
Measured: 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).
Measured: 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).
Measured: 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-∞).
Measured: Before and after co-administration of omeprazole, approximately day1 and day8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start24 May 2023
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MaleStudies of the same condition, open and under way.
- More trials run by InventisBio Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105255
- Sponsor's protocol ID
- D1553-107
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06105255
- Acronym / sponsor ID
- D1553-107
- Conditions
- Healthy Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 May 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multipledose D-1553 on PK of single dose midazolam, caffeine, rosuvastatin, furosemide, digoxin | Experimental | Drug: D-1553To 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. |
| Evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553 | Experimental | Drug: D-1553To evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553 tablets in healthy male subjects. |
| Evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553 | Experimental | Drug: D-1553To evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553 tablets in healthy male subjects. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-1553Also: otherD-1553 is a novel, targeted KRASG12C inhibitor. | Drug | 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 |
Primary outcome
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).
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).
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-∞).
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).
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).
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-∞).
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).
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).
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-∞).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D-1553 in people with Healthy Male, run by InventisBio Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.