CompletedPhase 1

Drug-durg Interaction of SHR3680 With Digoxin, Rosuvastatin Calcium and Metformin Hydrochloride

China36 participantsStarted 2021-01-08

Plain-language summary

The DDI study had been designed to investigate the effect of SHR3680 on the pharmacokinetics of digoxin, Rosuvastatin calcium and metformin hydrochloride.

Who can participate

Age range

18 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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) :
. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Summary of Pharmacokinetic parameters Maximum Plasma concentration (Cmax) for digoxin, Rosuvastatin calcium, metformin hydrochloride

Timeframe: 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

Timeframe: 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

Timeframe: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19

Trial details

NCT IDNCT04621669

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-08

View on ClinicalTrials.gov More Drug-drug Interaction,SHR3680 trials

Who can participate

Age range

18 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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) :
. 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.

Exclusion criteria

What they're measuring

Summary of Pharmacokinetic parameters Maximum Plasma concentration (Cmax) for digoxin, Rosuvastatin calcium, metformin hydrochloride

Timeframe: 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

Timeframe: For digoxin and Rosuvastatin calcium group：Day1 and Day22；For metformin hydrochloride group：Day1 and Day19