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

NCT04676035 | Completed Phase 1

• 1 other identifier: SHR3680-I-DDI-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer Patients

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics parameters of Midazolam, S-Warfarin and Omeprazole

  Peak Plasma Concentration (Cmax)

  Day1 and Day22

• Pharmacokinetics parameters of Midazolam, S-Warfarin and Omeprazole

  Area under the plasma concentration versus time curve (AUC)

  Day1 and Day22

Study Arms (1)

SHR3680+ Midazolam, Warfarin, Omeprazole, VitaminK1

EXPERIMENTAL

administrate Midazolam, Warfarin, Omeprazole, VitaminK1 on Day1 and Day22, SHR3680 on day 6-27.

Drug: Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680

Interventions

Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680 DRUG

* 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

SHR3680+ Midazolam, Warfarin, Omeprazole, VitaminK1

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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;
• 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.

You may not qualify if:

• \. 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;
• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

Midazolam; Warfarin; Omeprazole

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: December 19, 2020
• Study Start: June 15, 2020
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

CN (1)