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Malignant TumorPhase 1NCT06093945

Effect of Omeprazole on Pharmacokinetics of SHR2554 in Healthy Subjects

A Phase 1 study testing SHR2554 tablet dosing and Omeprazole tablet dosing in people with Malignant Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study aimed to assess the effects of omeprazole on single-dose SHR2554 in healthy subjects, exploring the pharmacokinetic changes of SHR2554 and ensuring the safety when SHR2554 is co-administered with omeprazole. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Malignant Tumor
What is being tested?
SHR2554 tablet dosing and Omeprazole tablet dosing
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
6 Nov 2023to 29 Nov 2023
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 an informed consent form before the trial and have a full understanding of the trial's content, procedures, and potential adverse reactions.
  • Be able to complete the study according to the trial protocol.
  • Healthy male and female subjects aged 18 to 45 (inclusive) on the day of signing the informed consent form.
  • Female subjects of childbearing potential must use effective contraception for 1 month from the date of signing the informed consent form until the last dose. Serum HCG testing before dosing must be negative. Male subjects with partners of childbearing potential must agree to use effective contraception measures and avoid sperm donation during the trial and for 1 month after the last administration of SHR2554.
  • Male subjects must weigh at least 50 kg, and female subjects must weigh at least 45 kg, with a body mass index (BMI) ranging from 19 kg/m2 to 26 kg/m2 (inclusive).
  • Health Condition: No history of heart, liver, kidney, gastrointestinal, neurological, psychiatric abnormalities, or metabolic disorders.
  • Normal or clinically insignificant findings in vital signs, physical examination, routine laboratory tests (complete blood count, blood biochemistry, urinalysis, coagulation function, myocardial enzyme profile, thyroid function), echocardiography, posteroanterior chest X-ray, and abdominal ultrasound.
  • Fridericia-corrected QT interval (QTcF) of males should ≤ 430 ms, and ≤ 450 ms for females. Left ventricular ejection fraction (LVEF) should ≥ 50%.

Who cannot join

  • Positive results on screening tests for hepatitis B surface antigen, hepatitis C antibodies, syphilis spirochete antibodies, or HIV antibodies.
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to SHR2554, its excipients, or drugs with a similar chemical structure or class.
  • Poorly controlled clinical heart symptoms or diseases such as: (1) NYHA Class 2 or higher heart failure; (2) Unstable angina; (3) Myocardial infarction within the past year; (4) Any supraventricular or ventricular arrhythmia requiring treatment or intervention.
  • Occurrence of any of the following conditions within the past 6 months before screening: Myocardial infarction, severe/unstable angina, NYHA Class II-IV heart failure, continuous arrhythmias of ≥ Grade 2 (graded based on NCI CTCAE 5.0), heart failure, second or third-degree atrioventricular block, complete left bundle branch block, any grade of atrial fibrillation, coronary/peripheral artery bypass grafting or stent implantation, cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis.
  • Use of any medication within the 4 weeks prior to the initial dose that carries a risk of prolonged QT/QTc interval or causing torsades de pointes (TdP) arrhythmia; a history of congenital QT interval prolongation syndrome or a family history of QT interval prolongation; presence of an implanted pacemaker or automated implantable cardioverter-defibrillator; uncorrected electrolyte disturbances, or any factors affecting QT/QTc studies.
  • Pulmonary diseases, including infiltrative lung diseases, pneumonia, and respiratory distress.
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  • Chronic kidney disease, renal insufficiency, or a history of renal anemia.
  • History of difficulty swallowing or any gastrointestinal disorders that affect drug absorption.
  • Any uncontrolled digestive ulcers, colitis, pancreatitis, etc.
  • Other primary diseases of important organs, such as neurological, cardiovascular, urological, digestive, respiratory, metabolic, and musculoskeletal system disorders, which makes the investigator believes it is unsuitable for participation in this study.
  • Subjects who have undergone any surgery within 3 months prior to screening that could affect drug absorption, distribution, metabolism, or elimination.
  • Subjects who have undergone any surgery within 6 months prior to screening.
  • Subjects who have taken hepatotoxic drugs (such as acetaminophen, erythromycin, fluconazole, ketoconazole, rifampin, etc.) within 6 months prior to screening.
  • Subjects who have participated in a clinical trial within 3 months prior to screening.
  • Subjects who have taken known CYP3A or CYP2C19 inducers/inhibitors (see Appendices 2 and 3) within 28 days prior to the first administration of SHR2554.
  • Subjects who have taken any prescription or non-prescription medications within 7 days prior to the first administration of SHR2554.
  • Subjects who have consumed any vitamin products or herbal supplements within 7 days prior to the first administration of SHR2554.
  • Subjects who abuse alcohol or excessive intake of alcohol within 6 months prior to screening, defined as consuming more than 14 units of alcohol per week (1 unit = 285 mL of beer, 25 mL of 40% alcohol, or 100 mL of wine); or subjects with an alcohol breath test result ≥20 mg/dL during screening.
  • Subjects who have smoked more than 5 cigarettes per day or habitually use nicotine-containing products within 3 months prior to screening, and are unable to quit during the study or have a positive nicotine screening result during screening.
  • Subjects who misuse drugs or have used recreational drugs (such as cannabis) within 3 months prior to screening, or have used hard drugs (such as cocaine, amphetamines, ecstasy, etc.) within the past year, or have a positive result on drug abuse (substance abuse) screening during screening.
  • Subjects who have consumed grapefruit or grapefruit-containing products, caffeine, xanthine, or alcohol-containing foods or beverages within 48 hours prior to the first administration of SHR2554; engaged in strenuous exercise, or have other factors that may affect drug absorption, distribution, metabolism, or excretion.
  • Subjects who habitually consume grapefruit juice or excessive amounts of tea, coffee, and/or caffeinated beverages, and are unable to abstain during the study.
  • Subjects who donated blood within the last 3 months and donated ≥400 mL of blood or experienced blood loss ≥400 mL, donated blood within the last 1 month and donated ≥200 mL of blood or experienced blood loss ≥200 mL, or received a blood transfusion.
  • Subjects with a history of syncope or vasovagal episodes, difficulty with blood collection, or an inability to tolerate venipuncture.
  • Subjects who, in the opinion of the investigator, have other factors that make them unsuitable for participation in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 318000

Other trials in China

About this study

Official title: Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics of SHR2554 in Healthy Subjects: A Single-center, Open-label, Single-dose, Two-period, Fixed Sequence, Self-controlled Study

The study aimed to assess the effects of omeprazole on single-dose SHR2554 in healthy subjects, exploring the pharmacokinetic changes of SHR2554 and ensuring the safety when SHR2554 is co-administered with omeprazole.

Conditions
Malignant Tumor
Being tested
SHR2554 tablet dosing, Omeprazole tablet dosing
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR2554 tablet dosingDrug

    SHR2554 350mg taken on Day 1 and Day 10

  • Omeprazole tablet dosingDrug

    Omeprazole taken from Days 5 to Day 10

Study groups in NCT06093945
Study groupRoleWhat they receive
SHR2554 and omeprazoleExperimentalSequential treatments of SHR2554 alone followed by SHR2554+ omeprazole, with a washout period in between.
Receives: Drug: SHR2554 tablet dosing; Drug: Omeprazole tablet dosing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of SHR2554: Rate and extent of absorption of SHR2554 following single oral doses of SHR2554 by assessment of maximum plasma concentration.

    Measured: PK samples collected in both period 1 and 2 at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post SHR2554 dose

  2. AUC0-t of SHR2554: Assessment of the PK of SHR2554 using area under the plasma concentration curve from zero extrapolated to o the time of the last quantifiable concentration.

    Measured: PK samples collected in both period 1 and 2 at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post SHR2554 dose

  3. AUC0-∞ of SHR2554: Assessment of the PK of SHR2554 using area under the plasma concentration-time curve from zero to infinity.

    Measured: PK samples collected in both period 1 and 2 at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post SHR2554 dose

  4. Tmax of SHR2554: Assessment of the PK of SHR2554 using time to reach maximum plasma concentration.

    Measured: PK samples collected in both period 1 and 2 at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post SHR2554 dose

  5. t1/2 of SHR2554: Assessment of the PK of SHR2554 using the terminal half-life.

    Measured: PK samples collected in both period 1 and 2 at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post SHR2554 dose

  6. CL/F of SHR2554: Assessment of the PK of SHR2554 using the apparent plasma clearance.

    Measured: PK samples collected in both period 1 and 2 at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post SHR2554 dose

  7. Vz/F of SHR2554: Assessment of the PK of AZD9291 using the apparent volume of distribution.

    Measured: PK samples collected in both period 1 and 2 at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post SHR2554 dose

Secondary outcomes (2)

  1. Incidence and severity of adverse events/serious adverse events

    Measured: From Day 1 to Day 15

  2. Change in Fridericia-corrected QTc interval (QTcF) relative to baseline (ΔQTcF)

    Measured: ECG samples collected in period 1 at pre-dose,1, 2, 3, 4, 6, 8, 12, and 24 hours post SHR2554 dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start6 Nov 2023
  3. Primary completion29 Nov 2023
  4. Study completion29 Nov 2023

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, single-dose, two-period, fixed sequence, self-controlled study
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06093945
Sponsor's protocol ID
SHR2554-112
Status last verified
Dec 2023
First submitted
17 Oct 2023
Last updated
5 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR2554 tablet dosing and Omeprazole tablet dosing in people with Malignant 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 8 inclusion and 25 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 5 Dec 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 of SHR2554: Rate and extent of absorption of SHR2554 following single oral doses of SHR2554 by assessment of maximum plasma concentration. (time frame: PK samples collected in both period 1 and 2 at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post SHR2554 dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06093945.

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 5 Dec 2023.

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