Clinical trial NCT04989829: Effect of Omeprazole on the Pharmacokinetics of SHR6390 in Healthy Subjects
Official title: A Single-centre, One-arm, Open-label, Fixed-sequence Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SHR6390 in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a single-center, open, single-dose, Fixed-sequence clinical trial.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a one-arm, fixed-sequence study to compare the pharmacokinetic profiles of SHR6390 in absence and presence of prior administration of proton pump inhibitor Omeprazole. The increased gastric pH achieved by the treatment with multiple doses of Omeprazole might affect the absorption process of SHR6390.


Eligibility criteria: Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Subjects shall ake effective contraceptive measures voluntarily within 7 months from the date of signing the informed consent form to the date of the last medication. Serum HCG test of fertile women before the study must be negative;
5. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);
6. Healthy subjects identified by a detailed medical history;
7. Full physical examinations, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory test, are normal or abnormal but have no clinical significance.

Exclusion Criteria:

1. Blood donation or loss≥400 mL within 3 months prior to screening, or blood donation or loss≥200 mL, or blood transfusion within 1 months before screening;
2. Participating in any clinical trial or taking drugs that might damage organs within 3 months before screening;
3. Surgeries in the previous 6 months before screening;
4. Use of vaccines or biologicals within 2 weeks prior to screening;
5. Allergic constitution;
6. History of drug abuse or alcoholism, or positive for nicotine, alcohol and drug tests;
7. History of myocarditis, coronary heart disease, arrhythmia, stroke and so on, or 12 lead ECG demonstrating a corrected QT by Fridericia (QTcF) interval ≥450 msec;
8. With dysphagia or history of gut disease or surgery (gastrectomy, enterectomy, sleeve gastrectomy, etc) possibly affecting drug absorption;
9. Uncontrolled gut disease, such as peptic ulcer, colitis, pancreatitis, etc;
10. History of chronic kidney disease, renal insufficiency, anemia of renal failure, or creatinine clearance rate (CLCr) \< 80 mL/min, or serum creatinine ≥ ULN.

Primary outcomes:
measure: Cmax
timeFrame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
measure: AUC0-t
timeFrame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
measure: AUC0-∞
timeFrame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
Secondary outcomes:
measure: Tmax
timeFrame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
measure: T1/2
timeFrame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
measure: CL/F
timeFrame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
measure: Vz/F
timeFrame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
measure: Number of subjects with adverse events and severity of adverse events
timeFrame: from Day1 to Day30 after the first dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
References: