Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether daily treatment with SHR3680 affects the ventricular repolarization in participants with Castration-Resistant Prostate Cancer (CRPC).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR3680 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR3680 tablets | Drug | Subjects start taking SHR3680 tablets 240 mg/dose/day orally on an empty stomach on D1, and the timing of administration daily should be consistent when possible. |
| Measure | Description | Time Frame |
|---|---|---|
| Delta QTc Fridericia (QTcF) | Mean change from baseline in QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake. | Day -1 and Day 1 and Day 17 |
| Concentration-delta QTcF relationship | Relationship between SHR3680 plasma concentration and delta QTcF based on linear-mixed effect model. | Day -1 and Day 1 and Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Electrocardiographic parameters Delta PR | A change from time-matched baseline measurements in PR interval will be determined on Day -1, Day 1 and Day 17. | Day -1 and Day 1 and Day 17 |
| Electrocardiographic parameters Delta RR |
Not provided
Inclusion Criteria:
Male between 18 years to 75 years of age;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
Expected survival of at least 6 months;
Histologically or cytologically confirmed adenocarcinoma of the prostate without indication of neuroendocrine or small cell features; nonmetastatic castration-resistant prostate cancer (NM-CRPC) or metastatic castration-resistant prostate cancer (mCRPC) ;
Be surgically or medically castrated and if treated with a gonadotropin releasing hormone analog (ie, patient who has not undergone bilateral orchiectomy), then this therapy must have been initiated at least 4 weeks prior to Day 1 and must be continued throughout the study;
Castrated level of testosterone at screening (≦ 50 ng/dL or 1.73 nmol/L);
Organ function level must meet the following requirements (blood transfusion or hematopoietic growth factor therapy was not received within 2 weeks before blood test):
12-lead ECG: heart rate ≥ 50 beats/min, PR interval within 110-220 ms (including both ends), QTc interval corrected according to Fridericia 's criteria (QTcF) < 470 msec. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography;
Able to complete the study as required by the protocol;
Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YIKE WANG, Pharm.D | Contact | +86-134-0862-8814 | yike.wang@hengrui.com | |
| Shaorong Li, Ph.D | Contact | +86-180-0162-4511 | shaorong.li@hengrui.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Tianjin | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multiple dose of SHR3680 will be administered
Not provided
Not provided
Not provided
Not provided
A change from time-matched baseline measurements in RR interval will be determined on Day -1, Day 1 and Day 17.
| Day -1 and Day 1 and Day 17 |
| Electrocardiographic parameters Delta QRS | A change from time-matched baseline measurements in QRS interval will be determined on Day -1, Day 1 and Day 17. | Day -1 and Day 1 and Day 17 |
| Electrocardiographic parameters Delta QTc Bazett (QTcB) | Mean change from baseline in QTcB as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake. | Day -1 and Day 1 and Day 17 |
| Electrocardiographic parameters T-wave morphology | Number and percentage of participants with changes from baseline | Day -1 and Day 1 and Day 17 |
| Electrocardiographic parameters U-wave morphology | Number and percentage of participants with changes from baseline | Day -1 and Day 1 and Day 17 |
| Incidence and severity of AE/SAE/AESI (rated based on CTCAE v5.0) | Participants will be monitored for safety during the Screening and Treatment Phases, and up to 30 days after the last dose of study drug. From the end of treatment phase onward collection of AE will be limited to Grade 3 or higher, all SAE and AESI from the remainder of the study. | Day-1, Day 1 to Day 18 |
| Pharmacokinetic parameter area under the plasma drug concentration-time curve (AUC) from time 0 to 24 hours | Day 1-2 and Day 17-18 |
| Pharmacokinetic parameter maximum concentration observed (Cmax) | Day 1-2 and Day 17-18 |
| Pharmacokinetic parameter time to reach Cmax (tmax) | Day 1-2 and Day 17-18 |
| Pharmacokinetic parameter minimum observed plasma concentration at steady-state (Cmin,ss) | Cmin,ss will only be collected on Day 17 |
| Pharmacokinetic parameter accumulation ratio(Rac) | Day 1-2 and Day 17-18 |