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Malignant TumorPhase 1NCT05592262

Pharmacokinetic Test of High-fat Diet After Oral Administration of SHR2554 in Healthy Subjects

A Phase 1 study testing SHR2554 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 objective of the study is to assess the effect of food on the pharmacokinetics, and safety of SHR2554 Tablets in healthy subjects. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
15 Nov 2022to 14 Dec 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

  • Healthy male and female subjects aged between 18 and 45 (inclusive) at the time of signing the informed consent;
  • Body weight ≥ 50.0 kg for men and body weight ≥ 45.0 kg for women, and body mass index (BMI) within the range of 19.0 to 26.0 kg /m2 (inclusive);
  • The mean value of three 12-lead ECG tests was normal or abnormal but not clinically significant, the time limit from Q wave to T wave was < 430 msec for male (QTcF), and < 450 msec for female (QTcF), and the heart rate was in the normal range or abnormal but not clinically significant.
  • Creatinine clearance (CLCr) ≥80 mL/min, and creatinine is less than or equal to the upper limit of normal value;
  • Participants should have no fertility plan from signing the informed consent until 6 months after the last medication, take effective contraceptive measures voluntarily and have no sperm donation plan. The serum HCG test of fertile women must be negative before Screening;
  • Participants should sign the informed consent before the study, and fully understand the content, process and possible adverse reactions of the study.

Who cannot join

  • Patients with abnormal vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg) or abnormal physical examination, laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram and other tests with clinical significance;
  • Abnormal X-ray examination with clinical significance;
  • Hepatitis B surface antigen, hepatitis C antibody and treponema pallidum antibody are positive or HIV antibody is not negative;
  • Allergic constitution, including history of severe drug allergy or drug allergy; Allergic history to SHR2554 tablets or the excipients thereof;
  • Previous history of cardiovascular diseases such as myocarditis, coronary heart disease, pathological arrhythmia, stroke, etc.;
  • Lung diseases, including invasive lung disease, pneumonia, dyspnea, etc.;
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  • History of chronic kidney disease, renal insufficiency, and renal anemia;
  • History of dysphagia or any gastrointestinal disease that affects drug absorption;
  • Any uncontrolled peptic ulcer, colitis, pancreatitis, etc.;
  • Other important organs of primary diseases, such as the nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism, and clear history of musculoskeletal system including but not limited to tumor patient or a history of cancer, such as not good control of diabetes, high blood pressure, etc.), the researchers think that don't fit for the researchers;
  • Patients who had undergone any surgery that would affect drug absorption, distribution, metabolism, or excretion within 3 months prior to screening;
  • Took hepatotoxic drugs (e.g. Dapsone, erythromycin, fluconazole, ketoconazole, rifampin) within 6 months before screening;
  • Candidates who participated in clinical trials within 3 months before screening;
  • Took any drug that alters the activity of liver enzymes within 28 days prior to taking the study drug;
  • Took any prescription or over-the-counter medications in the 7 days prior to taking the study drug;
  • Took any vitamin products or herbs in the 7 days prior to taking the study drug;
  • History of substance abuse, drug use and/or alcohol abuse: a history of substance abuse in the 6 months prior to screening, or a positive urine substance abuse screening test in the screening/baseline period, or drug use in the 3 months prior to screening; Heavy drinkers (14 units of alcohol per week: 1 unit = 285mL beer, 25mL liquor, or 100mL wine; Smoking ≥5 cigarettes per day), or having a positive alcohol breath test during the screening period/baseline, or being unable to smoke or abstain during the trial;
  • Drinking grapefruit juice, beverages containing xanthine, caffeine, alcohol, strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion within 48 hours before taking the study drug;
  • Participants who donated blood ≥400 mL or lost blood ≥400 mL within 3 months before screening, or received blood transfusion;
  • Patients with a history of needle sickness and blood sickness have difficulty in blood collection or cannot tolerate venipuncture blood collection;
  • Other factors considered by the investigator to be inappropriate for trial participation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Randomized, Open-label, Single-dose, Two-cycle, Two-sequence, Cross-controlled Study Evaluating the Pharmacokinetic Effects of a High-fat Diet on Oral Administration of SHR2554 Tablets in Healthy Adult Subjects in China

The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of SHR2554 Tablets in healthy subjects.

Conditions
Malignant Tumor
Being tested
SHR2554
Medical subject headings
Neoplasms

What participants receive

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

  • SHR2554Drug

    On an empty stomach - after meals

  • SHR2554Drug

    After meals - on an empty stomach

Study groups in NCT05592262
Study groupRoleWhat they receive
Treatment group AExperimentalNot described
Receives: Drug: SHR2554
Treatment group BExperimentalNot described
Receives: Drug: SHR2554

What is being measured

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

  1. Pharmacokinetic parameters of SHR2554: Cmax

    Measured: day 1 to day 10

  2. Pharmacokinetic parameters of SHR2554: AUC0-t

    Measured: day 1 to day 10

  3. Pharmacokinetic parameters of SHR2554: AUC0-∞ (if applicable)

    Measured: day 1 to day 10

Secondary outcomes (5)

  1. Pharmacokinetic parameters of SHR2554: Tmax

    Measured: day 1 to day 10

  2. Pharmacokinetic parameters of SHR2554: t1/2

    Measured: day 1 to day 10

  3. Pharmacokinetic parameters of SHR2554: CL/F

    Measured: day 1 to day 10

  4. Pharmacokinetic parameters of SHR2554: Vz/F

    Measured: day 1 to day 10

  5. The incidence and severity of adverse events/serious adverse events.

    Measured: from ICF signing date to approximate day 17

Timeline

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

  1. First posted24 Oct 2022
  2. Study start15 Nov 2022
  3. Primary completion14 Dec 2022
  4. Study completion14 Dec 2022

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
Randomised
Intervention model
Crossover
Model description
Randomized, open-label, single-dose, two-cycle, two-sequence, cross-controlled
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05592262
Sponsor's protocol ID
SHR2554-I-109
Status last verified
Dec 2022
First submitted
20 Oct 2022
Last updated
19 Dec 2022
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 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 6 inclusion and 21 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 19 Dec 2022. 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?

Pharmacokinetic parameters of SHR2554: Cmax (time frame: day 1 to day 10). 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?

On the ClinicalTrials.gov record for NCT05592262.

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 19 Dec 2022.

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