Healthy SubjectsPhase 1NCT07875842
A Phase I Study of the Interaction of D-2570 With Other Drugs in Healthy Adults
A Phase 1 study testing Itraconazole, Rifampicin and Omeprazole in people with Healthy Subjects, run by InventisBio Co., Ltd at 1 site in China.
Trial summary
The primary purpose of this study is to characterize the drug-drug interaction profiles of D-2570 with midazolam, digoxin, rosuvastatin, metformin, itraconazole, rifampicin, and omeprazole. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Itraconazole, Rifampicin and Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- After full informed consent, voluntarily participate in this study and sign the written Informed Consent Form (ICF), and agree to abide by the procedures specified in the study protocol;
- No pregnancy, sperm donation or egg donation plan from the start of screening to 30 days after the last administration of investigational product, and agree to completely abstain from sexual activity or adopt effective contraceptive measures throughout the period from screening to 30 days after the last administration of investigational product;
- Male or female trial participants aged 18 to 45 years old (inclusive of 18 and 45 years old);
- Male trial participants weigh no less than 50 kg, female trial participants weigh no less than 45 kg. Body Mass Index (BMI) = weight (kg) / height² (m²), and the Body Mass Index is within the range of 19 ~ 26 kg/m² (inclusive of the critical values);
- Vital signs, physical examination, laboratory tests, electrocardiogram, abdominal color ultrasound (liver, gallbladder, spleen, pancreas, bilateral kidneys) and chest X-ray (anteroposterior view) results are normal, or abnormal findings are judged by the investigator to be clinically insignificant.
Who cannot join
- History of herpes zoster or severe herpes simplex, or presence of herpes zoster/herpes simplex during the screening period;
- Individuals who cannot tolerate venipuncture/indwelling needle blood collection, or have needle phobia and hemophobia;
- Previously received surgeries that may affect drug absorption, distribution, metabolism and excretion, and are judged by the investigator to be unsuitable for enrollment;
- Individuals with a history of drug or substance abuse, or with a positive urine drug abuse screening result;
- Trial participants who have other factors that the investigator considers inappropriate to participate in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Huan Zhou, Doctor, 13665527160, zhouhuanbest@vip.163.com
Huan Zhou, 13665527160, zhouhuanbest@vip.163.com
About this study
Official title: A Phase I Study to Evaluate the Effect of D-2570 on the Pharmacokinetics of Midazolam, Digoxin,Rosuvastatin and Metformin, as Well as the Effect of Itraconazole, Rifampicin and Omeprazole on the Pharmacokinetics of D-2570 in Healthy Trial Participants
The primary purpose of this study is to characterize the drug-drug interaction profiles of D-2570 with midazolam, digoxin, rosuvastatin, metformin, itraconazole, rifampicin, and omeprazole.
Read the detailed description
The drug-drug interaction study is meant to evaluate the pharmacokinetics and safety of D-2570 tablet combined Midazolam, Digoxin,Rosuvastatin and Metformin, Itraconazole, Rifampicin and Omeprazole in Healthy Trial Participants
- Conditions
- Healthy Subjects
- Being tested
- Itraconazole, Rifampicin, Omeprazole, D-2570, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
Once daily on specified days
RifampicinDrug
Once daily on specified days
OmeprazoleDrug
Once daily on specified days
D-2570Drug
Once daily on specified days
MidazolamDrug
Once daily on specified days
DigoxinDrug
Once daily on specified days
RosuvastatinDrug
Once daily on specified days
MetforminDrug
Once daily on specified days
| Study group | Role | What they receive |
|---|---|---|
| Coadministration of D-2570 Tablets and Itraconazole | Experimental | The DDI study of D2570 and Itraconazole Receives: Drug: Itraconazole; Drug: D-2570 |
| Coadministration of D-2570 Tablets and Rifampicin | Experimental | The DDI study of D2570 and Itraconazole Receives: Drug: Rifampicin; Drug: D-2570 |
| Coadministration of D-2570 Tablets and Omeprazole | Experimental | The DDI study of D2570 and Rifampicin Receives: Drug: Omeprazole; Drug: D-2570 |
| Coadministration of D-2570 tablets and midazolam, digoxin, rosuvastatin, and metformin | Experimental | The DDI study of D2570 and midazolam, digoxin, rosuvastatin, and metformin Receives: Drug: D-2570; Drug: Midazolam; Drug: Digoxin; Drug: Rosuvastatin; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main PK parameters#Maximum observed plasma concentration-Cmax
The main PK parameters#Maximum observed plasma concentration-Cmax
Measured: through study completion, an average of 20 days
The main PK parameters#Area under the plasma concentration versus time curve-AUC
The main PK parameters#Area under the plasma concentration versus time curve-AUC
Measured: through study completion, an average of 20 days
Secondary outcomes (5)
Time to maximum measured plasma concentration -Tmax
Time to maximum measured plasma concentration -Tmax
Measured: through study completion, an average of 20 days
Half-life -t1/2
Half-life -t1/2
Measured: through study completion, an average of 20 days
CL/F (apparent clearance)
CL/F (apparent clearance)
Measured: through study completion, an average of 20 days
Vz/F (apparent volume of distribution)
Vz/F (apparent volume of distribution)
Measured: through study completion, an average of 20 days
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Incidence of adverse events
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start16 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huan Zhou, Doctor, Principal investigator, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875842
- Sponsor's protocol ID
- D2570-105
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Effect of D-2570 on the Pharmacokinetics of Midazolam, Digoxin,Rosuvastatin and Metformin, as Well as the Effect of Itraconazole, Rifampicin and Omeprazole on the Pharmacokinetics of D-2570 in Healthy Trial Participants
- ClinicalTrials.gov ID
- NCT07875842
- Acronym / sponsor ID
- D2570-105
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Oct 2026 (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.
The primary purpose of this study is to characterize the drug-drug interaction profiles of D-2570 with midazolam, digoxin, rosuvastatin, metformin, itraconazole, rifampicin, and omeprazole.
Detailed description
The drug-drug interaction study is meant to evaluate the pharmacokinetics and safety of D-2570 tablet combined Midazolam, Digoxin,Rosuvastatin and Metformin, Itraconazole, Rifampicin and Omeprazole in Healthy Trial Participants
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Coadministration of D-2570 Tablets and Itraconazole | Experimental | Drug: Itraconazole, Drug: D-2570The DDI study of D2570 and Itraconazole |
| Coadministration of D-2570 Tablets and Rifampicin | Experimental | Drug: Rifampicin, Drug: D-2570The DDI study of D2570 and Itraconazole |
| Coadministration of D-2570 Tablets and Omeprazole | Experimental | Drug: Omeprazole, Drug: D-2570The DDI study of D2570 and Rifampicin |
| Coadministration of D-2570 tablets and midazolam, digoxin, rosuvastatin, and metformin | Experimental | Drug: D-2570, Drug: Midazolam, Drug: Digoxin, Drug: Rosuvastatin, Drug: MetforminThe DDI study of D2570 and midazolam, digoxin, rosuvastatin, and metformin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- After full informed consent, voluntarily participate in this study and sign the written Informed Consent Form (ICF), and agree to abide by the procedures specified in the study protocol;
- No pregnancy, sperm donation or egg donation plan from the start of screening to 30 days after the last administration of investigational product, and agree to completely abstain from sexual activity or adopt effective contraceptive measures throughout the period from screening to 30 days after the last administration of investigational product;
- Male or female trial participants aged 18 to 45 years old (inclusive of 18 and 45 years old);
- Male trial participants weigh no less than 50 kg, female trial participants weigh no less than 45 kg. Body Mass Index (BMI) = weight (kg) / height² (m²), and the Body Mass Index is within the range of 19 ~ 26 kg/m² (inclusive of the critical values);
- Vital signs, physical examination, laboratory tests, electrocardiogram, abdominal color ultrasound (liver, gallbladder, spleen, pancreas, bilateral kidneys) and chest X-ray (anteroposterior view) results are normal, or abnormal findings are judged by the investigator to be clinically insignificant.
Key exclusion criteria (5 listed)
- History of herpes zoster or severe herpes simplex, or presence of herpes zoster/herpes simplex during the screening period;
- Individuals who cannot tolerate venipuncture/indwelling needle blood collection, or have needle phobia and hemophobia;
- Previously received surgeries that may affect drug absorption, distribution, metabolism and excretion, and are judged by the investigator to be unsuitable for enrollment;
- Individuals with a history of drug or substance abuse, or with a positive urine drug abuse screening result;
- Trial participants who have other factors that the investigator considers inappropriate to participate in this trial.
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 |
|---|---|---|
| ItraconazoleOnce daily on specified days | Drug | Coadministration of D-2570 Tablets and Itraconazole |
| RifampicinOnce daily on specified days | Drug | Coadministration of D-2570 Tablets and Rifampicin |
| OmeprazoleOnce daily on specified days | Drug | Coadministration of D-2570 Tablets and Omeprazole |
| D-2570Once daily on specified days | Drug | Coadministration of D-2570 Tablets and Itraconazole, Coadministration of D-2570 Tablets and Omeprazole, Coadministration of D-2570 Tablets and Rifampicin, Coadministration of D-2570 tablets and midazolam, digoxin, rosuvastatin, and metformin |
| MidazolamOnce daily on specified days | Drug | Coadministration of D-2570 tablets and midazolam, digoxin, rosuvastatin, and metformin |
| DigoxinOnce daily on specified days | Drug | Coadministration of D-2570 tablets and midazolam, digoxin, rosuvastatin, and metformin |
| RosuvastatinOnce daily on specified days | Drug | Coadministration of D-2570 tablets and midazolam, digoxin, rosuvastatin, and metformin |
| MetforminOnce daily on specified days | Drug | Coadministration of D-2570 tablets and midazolam, digoxin, rosuvastatin, and metformin |
Primary outcome
The main PK parameters#Maximum observed plasma concentration-Cmax
Time frame: through study completion, an average of 20 days
The main PK parameters#Maximum observed plasma concentration-Cmax
The main PK parameters#Area under the plasma concentration versus time curve-AUC
Time frame: through study completion, an average of 20 days
The main PK parameters#Area under the plasma concentration versus time curve-AUC
5 secondary outcomes
Time to maximum measured plasma concentration -Tmax
Time frame: through study completion, an average of 20 days
Half-life -t1/2
Time frame: through study completion, an average of 20 days
CL/F (apparent clearance)
Time frame: through study completion, an average of 20 days
Vz/F (apparent volume of distribution)
Time frame: through study completion, an average of 20 days
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Time frame: through study completion, an average of 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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.
Huan Zhou, Doctor principal investigator
The First Affiliated Hospital of Anhui Medical University
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 Itraconazole, Rifampicin and Omeprazole in people with Healthy Subjects, 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huan Zhou, Doctor (13665527160, zhouhuanbest@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main PK parameters#Maximum observed plasma concentration-Cmax (time frame: through study completion, an average of 20 days). The study lists 2 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 2026.