Effect of Omeprazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

NCT04989829 | Completed Phase 1

• 1 other identifier: SHR6390-I-113
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum observed serum concentration (Cmax) for SHR6390 after Single dose.

  from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose

• AUC0-t

  Area under the plasma concentration versus time curve (AUC0-t) for SHR6390 after Single dose

  from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose

• AUC0-∞

  Area under the plasma concentration versus time curve (AUC0-∞) for SHR6390 after Single dose

  from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose

Secondary Outcomes (5)

• Tmax

  from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose

• T1/2

  from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose

• CL/F

  from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose

• Vz/F

  from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose

• Number of subjects with adverse events and severity of adverse events

  from Day1 to Day30 after the first dose

Study Arms (1)

Treatment group

EXPERIMENTAL

Drug: SHR6390、Omeprazole

Interventions

SHR6390、Omeprazole DRUG

SHR6390 tablet single dose、Omeprazol single dose.

Treatment group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
• Ability to complete the study as required by the protocol;
• Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
• 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;
• 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);
• Healthy subjects identified by a detailed medical history;
• 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.

You may not qualify if:

• 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;
• Participating in any clinical trial or taking drugs that might damage organs within 3 months before screening;
• Surgeries in the previous 6 months before screening;
• Use of vaccines or biologicals within 2 weeks prior to screening;
• Allergic constitution;
• History of drug abuse or alcoholism, or positive for nicotine, alcohol and drug tests;
• 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;
• With dysphagia or history of gut disease or surgery (gastrectomy, enterectomy, sleeve gastrectomy, etc) possibly affecting drug absorption;
• Uncontrolled gut disease, such as peptic ulcer, colitis, pancreatitis, etc;
• History of chronic kidney disease, renal insufficiency, anemia of renal failure, or creatinine clearance rate (CLCr) \< 80 mL/min, or serum creatinine ≥ ULN.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

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

Model Details: The study is a single-center, open, single-dose, Fixed-sequence clinical trial.

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 4, 2021
• Study Start: December 27, 2021
• Primary Completion: January 26, 2022
• Study Completion: February 14, 2022
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

CN (1)