A Relative Bioavailability Study of Different Processes of SHR2554 Tablets in Healthy Adult Subjects

December 31, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Single-centre, Single-dose, Random, Open, Two-period, Cross-over Relative Bioavailability Study of Different Processes of SHR2554 Tablets in Healthy Adult Subjects

TThe study is being conducted to evaluate the relative bioavailability, pharmacokinetics and safety of different tablet processes of SHR2554 in healthy adult subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • The Affiliated Hospital of Nanjing University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of written informed consent and willing and able to participate this research.
  2. Health female or male aged 18 to 45 at date of informed consent.
  3. Weighing ≥45 kg for female and ≥50 kg for male, body mass index between 19.0 and 26.0 kg/m2.
  4. Normal or abnormal but with no clinically significant in physical examination, vital signs, laboratory tests (haematology, clinical chemistry, urinalysis, coagulation function), 12 lead ECG, abdominal B ultrasound and CT.
  5. Participants should have no fertility plan and take effective contraceptive measures voluntarily from 2 weeks prior dose (for female) until 3 months after the last dose (for both female and male), and have no sperm or ovum donation plan; for fertile women the serum HCG test must be negative within Screening.

Exclusion Criteria:

  1. Participants with chronic or serious disease history or current disease in respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., and are not suitable for enrollment as assessed by the investigator.
  2. Surgery history that may affect drug absorption in gastrointestinal tract (including gastrectomy, enterectomy, stomach reduction surgery, etc.).
  3. Surgery history within 6 months prior to screening or surgery plans during the study.
  4. Plasma donation or blood loss greater than 400 mL or transfusion within 3 months prior to screening, or greater than 200 mL within 1 month prior to screening.
  5. Positive results on screening tests for HBsAg and/or HCsAg and/or HIV and/or syphilis.
  6. History of drug abuse or positive results of drug tests.
  7. Alcohol abuse or smokers (≥14 units of alcohol per week within 6 months prior to screening: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine; ≥5 cigarettes per day), or unable to stop drinking or smoking during the study; positive results on screening tests for alcohol or nicotine.
  8. History of allergy/hypersensitivity (allergy/hypersensitivity to more than two substances), or are not suitable for enrollment as assessed by the investigator.
  9. Swallowing resistance or obstacles that affect drug absorption.
  10. Participation in any other clinical study that included drug treatment within 3 months prior to first SHR2554 dose.
  11. Administration of any CYP3A4 inducers or inhibitors within 4 weeks prior to first SHR2554 dose.
  12. Administration of any prescription/non-prescription medicine or traditional Chinese medicine or dietary supplement within 2 weeks prior to first SHR2554 dose.
  13. Administration of food or drinks that containing grapefruit, methylxanthine or alcohol within 72 hours prior to first SHR2554 dose; Strenuous exercise.
  14. Participants who have special dietary requirements and cannot accept a unified diet.
  15. Any factors that affect drug absorption, distribution, metabolism or excretion.
  16. Lactating women.
  17. History of fainting needles or blood; difficulty in blood collection or intolerance of venipuncture blood collection.
  18. Any factors are not suitable for enrollment as assessed by the investigator or participants withdrew from the study for their own reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group A
Drug: New Process SHR2554 tablet、Former Process SHR2554 tablet
New Process, 350 mg SHR2554 tablets on study day 1 - Former Process, 350 mg SHR2554 tablets on study day 8
Experimental: Treatment group B
Drug: Former Process SHR2554 tablet、New Process SHR2554 tablet
Former Process, 350 mg SHR2554 tablets on study day 1 - New Process, 350 mg SHR2554 tablets on study day 8

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cmax
Time Frame: day 1 to day 11
day 1 to day 11
AUC0-t
Time Frame: day 1 to day 11
day 1 to day 11
AUC0-∞
Time Frame: day 1 to day 11
day 1 to day 11
Tmax
Time Frame: day 1 to day 11
day 1 to day 11
t1/2
Time Frame: day 1 to day 11
day 1 to day 11
CL/F
Time Frame: day 1 to day 11
day 1 to day 11
Vz/F
Time Frame: day 1 to day 11
day 1 to day 11

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The incidence and severity of adverse events/serious adverse events
Time Frame: from ICF signing date to approximate day 15
from ICF signing date to approximate day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR2554-I-108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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