Advanced Solid TumorPhase 1NCT04989829
Effect of Omeprazole on the Pharmacokinetics of SHR6390 in Healthy Subjects
A Phase 1 study testing SHR6390、Omeprazole in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- SHR6390、Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2021to 14 Feb 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
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
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
- Being tested
- SHR6390、Omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR6390、OmeprazoleDrug
SHR6390 tablet single dose、Omeprazol single dose.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: SHR6390、Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed serum concentration (Cmax) for SHR6390 after Single dose.
Measured: 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
Measured: 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
Measured: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
Secondary outcomes (5)
Tmax
Time to maximum observed serum concentration (Tmax) for SHR6390 after Single dose
Measured: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
T1/2
Time to elimination half-life (T1/2) for SHR6390 after Single dose.[Time Frame
Measured: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
CL/F
Apparent oral clearance (CL/F) for SHR6390 after Single dose
Measured: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
Vz/F
Apparent Volume of Distribution (Vz/F) SHR6390 after Single dose
Measured: 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
Measured: from Day1 to Day30 after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start27 Dec 2021
- Primary completion26 Jan 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- The study is a single-center, open, single-dose, Fixed-sequence clinical trial.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989829
- Sponsor's protocol ID
- SHR6390-I-113
- Status last verified
- Jun 2023
- First submitted
- 3 Aug 2021
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04989829
- Acronym / sponsor ID
- SHR6390-I-113
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a single-center, open, single-dose, Fixed-sequence clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: SHR6390、Omeprazole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR6390、OmeprazoleSHR6390 tablet single dose、Omeprazol single dose. | Drug | Treatment group |
Primary outcome
Cmax
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
Maximum observed serum concentration (Cmax) for SHR6390 after Single dose.
AUC0-t
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
Area under the plasma concentration versus time curve (AUC0-t) for SHR6390 after Single dose
AUC0-∞
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
Area under the plasma concentration versus time curve (AUC0-∞) for SHR6390 after Single dose
5 secondary outcomes
Tmax
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
T1/2
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
CL/F
Time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose
Vz/F
Time frame: 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
Time frame: from Day1 to Day30 after the first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR6390、Omeprazole in people with Advanced Solid Tumor, 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 7 inclusion and 10 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 8 Jun 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?
Cmax (time frame: from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2023.