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Prostate Cancer PatientsPhase 1NCT04676035

The DDI Study Had Been Designed to Investigate the Effect of SHR3680 on the Pharmacokinetics of Midazolam, S-Warfarin and Omeprazole

A Phase 1 study testing Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680 in people with Prostate Cancer Patients, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The DDI study had been designed to investigate the effect of SHR3680 on the pharmacokinetics of Midazolam, S-Warfarin and Omeprazole 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?
Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
15 Jun 2020to 26 Jan 2022
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

  • 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;
  • 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) :
  • ANC ≧ 1.5 x 109 / L;
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  • 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

  • 1. 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 CYP3A4, CYP2C9 and CYP2C19 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 treated with anticoagulants or vitamin K1 antagonists such as warfarin, heparin, or similar drugs;
  • Note: Under the condition that the international standard ratio of prothrombin time (INR) ≤1.5, low-dose heparin (66,000-12,000U daily for adults) or low-dose aspirin (100mg daily) is allowed for preventive purposes;
  • Midazolam contraindications (benzodiazepine allergy, myasthenia gravis, schizophrenia, severe depression);
  • Contraindications to Warfarin (liver and kidney function impairment, severe hypertension, coagulation dysfunction with bleeding tendency, active ulcer, trauma, threatened abortion, recent surgery);
  • 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.

China1 site

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong

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 Midazolam （CYP3A4 Substrates), S-Warfarin (CYP2C9 Substrates) and Omeprazole (CYP2C19 Substrates) in Prostate Cancer Patients

The DDI study had been designed to investigate the effect of SHR3680 on the pharmacokinetics of Midazolam, S-Warfarin and Omeprazole

Being tested
Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680

What participants receive

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

  • Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680Drug

    • Experimental: Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680
    • Midazolam, Warfarin, Omeprazole and VitaminK1 QD on Day 1 and Day 22, SHR3680 240 mg once daily (QD) from Study Day 6 - 27
Study groups in NCT04676035
Study groupRoleWhat they receive
SHR3680+ Midazolam, Warfarin, Omeprazole, VitaminK1Experimentaladministrate Midazolam, Warfarin, Omeprazole, VitaminK1 on Day1 and Day22, SHR3680 on day 6-27.
Receives: Drug: Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680

What is being measured

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

  1. Pharmacokinetics parameters of Midazolam, S-Warfarin and Omeprazole

    Peak Plasma Concentration (Cmax)

    Measured: Day1 and Day22

  2. Pharmacokinetics parameters of Midazolam, S-Warfarin and Omeprazole

    Area under the plasma concentration versus time curve (AUC)

    Measured: Day1 and Day22

Timeline

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

  1. First posted19 Dec 2020
  2. Study start15 Jun 2020
  3. Primary completion26 Jan 2022
  4. Study completion26 Jan 2022

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04676035
Sponsor's protocol ID
SHR3680-I-DDI-01
Status last verified
Feb 2023
First submitted
22 Nov 2020
Last updated
9 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Midazolam, Warfarin, Omeprazole, VitaminK1 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 14 inclusion and 22 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 9 Feb 2023. 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?

Pharmacokinetics parameters of Midazolam, S-Warfarin and Omeprazole (time frame: Day1 and Day22). 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 NCT04676035.

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 9 Feb 2023.

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