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Prostate Cancer PatientsPhase 1NCT04664725

Drug-drug Interaction of SHR3680 With Repaglinide and Bupropion

A Phase 1 study testing Repaglinide, Bupropion and SHR3680 in people with Prostate Cancer Patients, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The DDI study had been designed to investigate the effect of SHR3680 on the pharmacokinetics of Repaglinide and Bupropion Read more about this study

Who is it for?
Ages 45 to 75 years, men only
Conditions the study is for
Prostate Cancer Patients
What is being tested?
Repaglinide, Bupropion and SHR3680
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
1 Jun 2020to May 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 45 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. 18 ≤ age ≤75, male;
  • ECOG score of physical condition is 0 ~ 1;
  • The expected survival time is at least 3 months;
  • Prostatic adenocarcinoma confirmed by histological or cytological examination, with no indication of neuroendocrine or small-cell characteristics;
  • Fasting blood glucose level is: 3.9～6.1mmol/L；
  • 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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  • ANC ≧ 1.5 x 109 / L;
  • PLT ≧ 80 x 109 / L;
  • Hb ≧ 90 g/L;
  • TBIL ≦1.5 x ULN;
  • ALT and AST≦2.5×ULN;
  • BUN and Cr ≦1.5 x ULN;
  • GFR ≧ 60 ml/min / 1.73 m2.
  • According to the researcher's judgment, it can comply with the experimental scheme;
  • Volunteer to participate in this clinical trial, understand the study procedures and have signed informed consent.

Who cannot join

  • 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;
  • 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);
  • 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;
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  • 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 (HBV copy count ≥ 104 copies /mL, HCV copy count ≥ 103 copies /mL) 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 = 360 mL of alcohol content of 5% beer or 45 mL of 40% alcohol liquor or 150 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 CYP2C8 and CYP2B6 inhibitors were used, or drugs affecting gastric acid secretion.;
  • 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;
  • Repaglinide contraindications (insulin-dependent -IDDM, C-peptide-negative diabetic patients, diabetic ketoacidosis with or without coma);
  • Contraindications to bulimia or anorexia (epileptic history, bulimia or anorexia, abstinence from alcohol or sedatives suddenly);
  • Those 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.

Yuya Wang, Ph.D contact

13918749176

wangyuya@hrglobe.cn

shijuan kuang, Master contact

13601827797

kuangshijuan@hrglobe.cn

China1 site, 1 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Weiqing Han, Ph.D, +86-18684699859, md70210@sina.com

    Recruiting

Other trials in China

About this study

Official title: A Single-center, Open-label, Fixed-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of SHR3680 With Repaglinide (CYP2C8 Substrates) and Bupropion (CYP2B6 Substrates) in Prostate Cancer Patients

The DDI study had been designed to investigate the effect of SHR3680 on the pharmacokinetics of Repaglinide and Bupropion

Being tested
Repaglinide, Bupropion and SHR3680

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repaglinide, Bupropion and SHR3680Drug

    Single dose of oral administration of Repaglinide and Bupropion, Multiple dose of oral of SHR3680

Study groups in NCT04664725
Study groupRoleWhat they receive
SHR3680+ Repaglinide, BupropionExperimental* Experimental: Repaglinide, Bupropion and SHR3680 * Repaglinide and Bupropion QD on Day 1 and Day 21, SHR3680 240 mg once daily (QD) from Study Day 6 - 26
Receives: Drug: Repaglinide, Bupropion and SHR3680

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Plasma Concentration(Cmax)

    Summary of Pharmacokinetic parameters Maximum Plasma concentration (Cmax) for Repaglinide and Bupropion

    Measured: Day1 and Day21

  2. Area under the plasma concentration versus time curve(AUC0-t)

    Summary of Pharmacokinetic parameters Area Under the Plasma Concentration-time Curve form 0 to any time before the last quantifiable concentration(AUC0-t)for Repaglinide and Bupropion

    Measured: Day1 and Day21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start1 Jun 2020
  3. Primary completionJan 2021 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04664725
Sponsor's protocol ID
SHR3680-I-DDI-02
Status last verified
Nov 2020
First submitted
22 Nov 2020
Last updated
11 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dai T, Xu Z, Huang L, Wang Y, Zeng G, Ye M, Liu K, Zeng F, Jiang S, Han W, Cao J. A single-centre, open-label, single-arm, fixed-sequence pharmacokinetic study of SHR3680 on repaglinide and bupropion in prostate cancer patients. Br J Clin Pharmacol. 2023 Feb;89(2):874-886. doi: 10.1111/bcp.15528. Epub 2022 Oct 9.

    PubMed 36098470

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Repaglinide, Bupropion and SHR3680 in people with Prostate Cancer Patients, 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 21 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: status not confirmed, as of the sponsor's last update on 11 Dec 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yuya Wang, Ph.D (13918749176, wangyuya@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration(Cmax) (time frame: Day1 and Day21). 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?

On the ClinicalTrials.gov record for NCT04664725, which also lists 1 linked publication.

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 11 Dec 2020.

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