CClinicalTrials.gg
CompletedNCT04989829Updated Jun 8, 2023

Effect of Omeprazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

A Phase 1 interventional study of SHR6390、Omeprazole in Advanced Solid Tumor, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-08.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Solid Tumor
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Treatment group

    Drug: SHR6390、Omeprazole

Interventions

  • DrugSHR6390、Omeprazole

    SHR6390 tablet single dose、Omeprazol single dose.

06

What researchers measure

Primary outcomes

  1. Cmax

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

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

  2. AUC0-t

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

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

  3. AUC0-∞

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

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

Secondary outcomes

  1. Tmax

    Time to maximum observed serum concentration (Tmax) for SHR6390 after Single dose

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

  2. T1/2

    Time to elimination half-life (T1/2) for SHR6390 after Single dose.\[Time Frame

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

  3. CL/F

    Apparent oral clearance (CL/F) for SHR6390 after Single dose

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

  4. Vz/F

    Apparent Volume of Distribution (Vz/F) SHR6390 after Single dose

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

  5. Number of subjects with adverse events and severity of adverse events

    Time frame: from Day1 to Day30 after the first dose

07

Study locations

1 site
  • Shanghai Xuhui Central Hospital
    Shanghai, Shanghai 200031, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04989829
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Aug 4, 2021
Start date
Dec 27, 2021
Primary completion
Jan 26, 2022
Completion
Feb 14, 2022
Last update
Jun 8, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion