Drug-drug Interaction,SHR3680Phase 1NCT04621669
Drug-durg Interaction of SHR3680 With Digoxin, Rosuvastatin Calcium and Metformin Hydrochloride
A Phase 1 study testing SHR3680, digoxin and Rosuvastatin calcium in people with Drug-drug Interaction,SHR3680, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The DDI study had been designed to investigate the effect of SHR3680 on the pharmacokinetics of digoxin, Rosuvastatin calcium and metformin hydrochloride. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Drug-drug Interaction,SHR3680
- What is being tested?
- SHR3680, digoxin and Rosuvastatin calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2021to 8 Sep 2021
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to enter the study:
- 18 ≤ age ≤75, male;
- ECOG score of physical condition is 0 ~ 1;
- The expected survival time is at least 3 months;
- Prostate adenocarcinoma confirmed by histological or cytological examination (can be included in mHSPC and mCRPC populations), with no neuroendocrine or small-cell characteristics;CRPC should also meet the following two conditions :(1) serum testosterone level of castration (< 1.7 nmol/L);(2) biochemical progression: prostate-specific antigen (PSA) was increased for 3 consecutive times at an interval of 1 week or more, and increased by more than 50% compared with the lowest value for 2 consecutive times, with PSA > 2 g/L.Or imaging progress: 2 or more new lesions or soft tissue lesions conforming to solid tumor response evaluation criteria were found on bone scan;
- The functional level of organs must meet the following requirements (no blood transfusion or hematopoietic growth factor treatment was received within 2 weeks before routine blood screening) :
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- the ANC ≧ 1.5 x 109 / L;
- PLT ≧ 80 x 109 / L;
- Hb ≧ 90 g/L; 1.5 x ULN - TBIL ≦;
- ALT and AST≦2.5×ULN;
- 1.5 x ULN Cr ≦;
- GFR ≧ 60 ml/min / 1.73 m2.
- According to the researcher's judgment, it can comply with the experimental scheme;
- In addition, in accordance with the requirements of regulatory authorities, research centers and relevant departments, and based on the judgment of researchers, you shall be tested for COVID-19 screening when necessary;
- Volunteer to participate in this clinical trial, understand the study procedures and have signed informed consent.
Who cannot join
- Subjects who meet any of the following criteria will not be admitted to the study:
- Any previous anti-tumor therapy (including radiotherapy, chemotherapy, surgery, molecular targeted therapy, immunotherapy, etc.), except ADT therapy, shall be completed until the washout period of the first drug administration in this study is <4 weeks;
- Plan to receive any other anti-tumor therapy during the study;
- As subjects, to participate in other drug clinical trials, the last trial drug administration is less than 4 weeks from the first administration of the drug in this study (except for the patients who have participated in ADT treatment before and have been out of the group, and the subjects who are still giving free ADT treatment);
- The presence of intracerebral tumor lesions according to imaging diagnosis;
- Have a history of epilepsy, or have diseases that can induce epileptic seizures within 12 months before the first administration of the drug in this study (including a history of transient ischemic attack, cerebral stroke (except cerebral ischemia lesions found by simple imaging examination), and need to be hospitalized with cerebral trauma and consciousness disorder);
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- Active heart disease, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and drug-requiring ventricular arrhythmias, within 6 months prior to the first administration of the drug in this study;
- Inability to swallow, chronic diarrhea and ileus, history of gastrointestinal surgery, or other factors affecting drug use and absorption as determined by the investigator;
- Patients with active HBV or HCV infection (HBsAg positive and virus copy number ≥500 IU/mL, HCV antibody positive and HCV RNA higher than the lower limit of analytical method detection) and active syphilis;
- A history of immunodeficiency (including HIV positive, other acquired or congenital immunodeficiency diseases) or a history of organ transplantation;
- Patients who were unwilling to use effective contraceptive methods during the whole study treatment period and within 3 months after the last administration;
- Allergic constitution, including a history of severe drug allergy or drug allergy;
- Screening for excessive smoking in the first 6 months (≥5 cigarettes/day) or smoking within 48 hours before the first dose, or not interrupting smokers during the main study trial, and screening for drug use in the first 3 months with a history of drug abuse or positive drug abuse screening;
- has a history of alcoholism or within 6 months prior to screening often drinkers, namely the essence of drinking more than 14 units of alcohol a week (1 = 285 mL of alcohol content of 5% beer or 25 mL of 40% alcohol liquor or 100 mL wine alcohol content of 12%) or within 48 h before taking the medicine for the first time drinking, or D - 1 in the alcohol breath test positive, or the body can't stop alcohol intake during the study period;
- Use of any vitamin product, health product or herb 14 days prior to the first administration;
- Ingestion of grapefruit or fruit juice products such as grapefruit, foods or beverages containing caffeine, xanthine or alcohol within 48 hours before taking the study drug;Strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion;
- Within 2 weeks before the first drug uptake, uptake transporter P-GP, BCRP, OATP1B1/1B3 or MATE1/2-K inhibitors were used, or drugs affecting gastric acid secretion.(Annex I);
- abnormal coagulation function at screening stage (INR >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT> 1.5uln), bleeding tendency or thrombolytic therapy;
- Patients with a history of fainting needle or blood, have difficulty in blood collection or cannot tolerate vein puncture for blood collection;
- Concomitant diseases (such as poorly controlled hypertension, severe diabetes, thyroid disease, psychosis, etc.) or any other conditions that, in the investigator's judgment, would seriously endanger the patient's safety or affect the patient's completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Open-label, Fixed-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of SHR3680 With Pgoxin (P-gp Substrates), Rosuvastatin Calcium (BCRP and OATP1B1/1B3 Substrates) and Metformin Hydrochloride (MATE1/2-K Substrates) in Prostate Cancer Patients
The DDI study had been designed to investigate the effect of SHR3680 on the pharmacokinetics of digoxin, Rosuvastatin calcium and metformin hydrochloride.
- Conditions
- Drug-drug Interaction,SHR3680
- Being tested
- SHR3680, digoxin, Rosuvastatin calcium, metformin hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR3680Drug
240 mg
digoxinDrug
0.25 mg
Rosuvastatin calciumDrug
10 mg
metformin hydrochlorideDrug
500 mg
| Study group | Role | What they receive |
|---|---|---|
| digoxin, Rosuvastatin calcium,SHR3680 | Experimental | Not described Receives: Drug: SHR3680; Drug: digoxin; Drug: Rosuvastatin calcium |
| metformin hydrochloride ,SHR3680 | Experimental | Not described Receives: Drug: SHR3680; Drug: metformin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Pharmacokinetic parameters Maximum Plasma concentration (Cmax) for digoxin, Rosuvastatin calcium, metformin hydrochloride
Measured: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
Summary of Pharmacokinetic parameters Area Under the Plasma Concentration-time Curve form 0 to any time before the last quantifiable concentration(AUC0-t)for digoxin, Rosuvastatin calcium, metformin hydrochloride
Measured: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
Summary of Pharmacokinetic parameters Area Under the Plasma Concentration-time Curve form 0 to infinite time(AUCinf)for digoxin, Rosuvastatin calcium, metformin hydrochloride
Measured: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
Secondary outcomes (5)
Tmax of digoxin, Rosuvastatin calcium, metformin hydrochloride
Measured: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
incidence of adverse events/serious adverse event
safety evaluation based on NCI-CTC AE 5.0
Measured: From ICF signing date to approximate 2 months
T1/2 of digoxin, Rosuvastatin calcium, metformin hydrochloride
Measured: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
CL/F of digoxin, Rosuvastatin calcium, metformin hydrochloride
Measured: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
Vz/F of digoxin, Rosuvastatin calcium, metformin hydrochloride
Measured: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start8 Jan 2021
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-drug Interaction,SHR3680Studies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To observe the effect of SHR3680 on the pharmacokinetics of digoxin, Rosuvastatin calcium, metformin hydrochloride and to evaluate the safety. The subjects will take digoxin, Rosuvastatin calcium, metformin hydrochloride at first single dose, then wash out ,and take it at second time together with SHR3680 after multiple administration of SHR3680
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621669
- Sponsor's protocol ID
- SHR3680-I-DDI-03
- Status last verified
- Jun 2026
- First submitted
- 3 Nov 2020
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Fixed-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of SHR3680 With Pgoxin (P-gp Substrates), Rosuvastatin Calcium (BCRP and OATP1B1/1B3 Substrates) and Metformin Hydrochloride (MATE1/2-K Substrates) in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT04621669
- Acronym / sponsor ID
- SHR3680-I-DDI-03
- Conditions
- Drug-drug Interaction,SHR3680
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 9 Nov 2020 (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 DDI study had been designed to investigate the effect of SHR3680 on the pharmacokinetics of digoxin, Rosuvastatin calcium and metformin hydrochloride.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To observe the effect of SHR3680 on the pharmacokinetics of digoxin, Rosuvastatin calcium, metformin hydrochloride and to evaluate the safety. The subjects will take digoxin, Rosuvastatin calcium, metformin hydrochloride at first single dose, then wash out ,and take it at second time together with SHR3680 after multiple administration of SHR3680
| Arm | Type | Receives |
|---|---|---|
| digoxin, Rosuvastatin calcium,SHR3680 | Experimental | Drug: SHR3680, Drug: digoxin, Drug: Rosuvastatin calcium |
| metformin hydrochloride ,SHR3680 | Experimental | Drug: SHR3680, Drug: metformin hydrochloride |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 18 ≤ age ≤75, male;
- ECOG score of physical condition is 0 ~ 1;
- The expected survival time is at least 3 months;
- Prostate adenocarcinoma confirmed by histological or cytological examination (can be included in mHSPC and mCRPC populations), with no neuroendocrine or small-cell characteristics;CRPC should also meet the following two conditions :(1) serum testosterone level of castration (< 1.7 nmol/L);(2) biochemical progression: prostate-specific antigen (PSA) was increased for 3 consecutive times at an interval of 1 week or more, and increased by more than 50% compared with the lowest value for 2 consecutive times, with PSA > 2 g/L.Or imaging progress: 2 or more new lesions or soft tissue lesions conforming to solid tumor response evaluation criteria were found on bone scan;
- The functional level of organs must meet the following requirements (no blood transfusion or hematopoietic growth factor treatment was received within 2 weeks before routine blood screening) :
Key exclusion criteria (20 listed)
- Any previous anti-tumor therapy (including radiotherapy, chemotherapy, surgery, molecular targeted therapy, immunotherapy, etc.), except ADT therapy, shall be completed until the washout period of the first drug administration in this study is <4 weeks;
- Plan to receive any other anti-tumor therapy during the study;
- As subjects, to participate in other drug clinical trials, the last trial drug administration is less than 4 weeks from the first administration of the drug in this study (except for the patients who have participated in ADT treatment before and have been out of the group, and the subjects who are still giving free ADT treatment);
- The presence of intracerebral tumor lesions according to imaging diagnosis;
- Have a history of epilepsy, or have diseases that can induce epileptic seizures within 12 months before the first administration of the drug in this study (including a history of transient ischemic attack, cerebral stroke (except cerebral ischemia lesions found by simple imaging examination), and need to be hospitalized with cerebral trauma and consciousness disorder);
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 |
|---|---|---|
| SHR3680240 mg | Drug | digoxin, Rosuvastatin calcium,SHR3680, metformin hydrochloride ,SHR3680 |
| digoxin0.25 mg | Drug | digoxin, Rosuvastatin calcium,SHR3680 |
| Rosuvastatin calcium10 mg | Drug | digoxin, Rosuvastatin calcium,SHR3680 |
| metformin hydrochloride500 mg | Drug | metformin hydrochloride ,SHR3680 |
Primary outcome
Summary of Pharmacokinetic parameters Maximum Plasma concentration (Cmax) for digoxin, Rosuvastatin calcium, metformin hydrochloride
Time frame: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
Summary of Pharmacokinetic parameters Area Under the Plasma Concentration-time Curve form 0 to any time before the last quantifiable concentration(AUC0-t)for digoxin, Rosuvastatin calcium, metformin hydrochloride
Time frame: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
Summary of Pharmacokinetic parameters Area Under the Plasma Concentration-time Curve form 0 to infinite time(AUCinf)for digoxin, Rosuvastatin calcium, metformin hydrochloride
Time frame: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
5 secondary outcomes
Tmax of digoxin, Rosuvastatin calcium, metformin hydrochloride
Time frame: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
incidence of adverse events/serious adverse event
Time frame: From ICF signing date to approximate 2 months
T1/2 of digoxin, Rosuvastatin calcium, metformin hydrochloride
Time frame: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
CL/F of digoxin, Rosuvastatin calcium, metformin hydrochloride
Time frame: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
Vz/F of digoxin, Rosuvastatin calcium, metformin hydrochloride
Time frame: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19
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 5 Jun 2026.
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 SHR3680, digoxin and Rosuvastatin calcium in people with Drug-drug Interaction,SHR3680, run by Jiangsu HengRui Medicine 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 15 inclusion and 20 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 5 Jun 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?
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?
Summary of Pharmacokinetic parameters Maximum Plasma concentration (Cmax) for digoxin, Rosuvastatin calcium, metformin hydrochloride (time frame: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19). The study lists 3 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 5 Jun 2026.