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
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.
- 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