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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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

Other trials in China

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

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 groups in NCT06105255
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.

24 May 20232 Feb 2024

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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.

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?

On the ClinicalTrials.gov record for NCT06105255.

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.