Trial of Chiauranib Capsule on Pharmacokinetics to Assess the Effect of High Fat Diet in Healthy Volunteers

February 8, 2023 updated by: Chipscreen Biosciences, Ltd.

A Randomized, Open-label, Single-dose, Single-center, Two-sequence, Two- Stage Phase I Trial of Chiauranib Capsule on Pharmacokinetics to Assess the Effect of High Fat Diet in Healthy Volunteers

The purpose of this study is to further study the pharmacokinetic characteristics of Chiauranib Capsule in Healthy Volunteers with High Fat Diet.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

This study is a Randomized, Open-label, Single-dose, Single-center, two-sequence, two- stage Phase I Trial. 16 Healthy Volunteers will be enrolled and Randomized into two arms. 8 Healthy Volunteers were in each arm. Arm A：Patients receive 50mg Chiauranib po only once In the fasting state and after 14 days receive 50mg Chiauranib po Only once with High Fat Diet. Arm B: Patients receive 50mg Chiauranib po only once with High Fat Diet and after 14 days receive 50mg Chiauranib po Only once In the fasting state. During the trial, Blood samples were collected.

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.
16

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
      • Suzhou, Jiangsu, China, 21500
        • The First Affiliated Hospital of Suzhou University

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. Ages: 18 Years to 45 Years
  2. 19≤BMI≤26. Weight of male ≥50 kg and Weight of female 45 kg
  3. at screening Healthy or NCS as determined by the Investigator based on physical examination, vital signs, a series of laboratory examinations（such as blood routine examination, et.al）and 12-lead electrocardiogram (ECG)
  4. Healthy Volunteers have no plan to fertilize throughout treatment and for at least 6 months after study is stopped
  5. Healthy Volunteers voluntarily sign informed consent
  6. Able to communicate well with the Investigator, to comply with the requirements of the study

Exclusion Criteria:

  1. Has known allegies to Chiauranib ,any of the excipients or Have a history of relevant atopy or drug hypersensitivity
  2. Being hypertension or having risk of hypertension, or SBP≥140 mmHg, DBP ≥90 mmHg; or Being hypotension or having risk of hypotension, or SBP < 90 mmHg, DBP < 60 mmHg
  3. Inability to take oral medication or having Gastrointestinal, liver and kidney diseases that affect drug absorption or metabolism within 6 months
  4. Prior to random Having uncured diarrhea or having 4 or more episodes of diarrhea within 7 days prior to scheduled drug administration
  5. Having any significant history of hemorrhagic disease or any history of coagulopathy
  6. A history of frequent and severe infection(≥3 episodes)within the past 1 year, or a history of severe infection within 3 months prior to drug administration；
  7. Ccr < 80 mL/min
  8. Difficulty of venous blood collection
  9. QTcF > 450 ms
  10. Drug abuse within 5 years or used drug within 3 months prior to the study, or Urine drug screening is positive during screening
  11. Heavy smokers(average daily smoking of more than 5 cigarettes/ day during past 3 months prior to screenig); heavy drinkers(average weekly drinking of more than 14 units of alcohol during past 6 months prior to screening, 1 unit =360 mL beer or 45 mL 40% spirits or 150 mL wine); Having Alcoholic products within 2 days prior to drug administration, or Alcohol breath test result ≥20 mg/dl
  12. Ingestion of prescription drugs, OTC drug, Vitamin, dietary supplements or herbal products within 14 days prior to screening
  13. Subjects who have taken any drugs known to induce or inhibit hepatic drug metabolism(CYP3A, CYP1A2 and CYP2D6)within 30 days prior to drug administration of the study medication, or Subjects who have taken any foods and drinks known to induce or inhibit hepatic drug metabolism within 7 days prior to drug administration
  14. Intake of Tea, Coffee or other Caffeinated beverage(more than 8 cups, 1 cup=250 mL)within 14 days prior to drug administration, Intake of any food or beverage containing or metabolized to produce caffeine or xanthine within 48 hours prior to drug administration
  15. Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication
  16. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test
  17. The abnormal result of C-reactive protein has clinical significance or Subjects testing positive for COVID-19
  18. Vaccinated within 1 month prior to screening or plan to Vaccinate during the study
  19. Females with a positive pregnancy test or Women of childbearing potential, pregnant and lactating women
  20. Volunteer in any other study within 3 months prior to drug administration, or Volunteer in 3 times or more studies
  21. Blood donation or lost more than 400mL blood within 3 months prior to the study, or Received blood transfusions within 1 month
  22. Patients received major surgical operations within 6 months prior to screening, or plan to received surgical operation during the study
  23. Extremes in food consumption practices
  24. Other situations that the researchers considered unsuitable to enroll the subject

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

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.
OTHER: Chiauranib(In the fasting state)
Experimental: Chiauranib Patients receive 50mg Chiauranib po only once In the fasting state and after 14 days receive 50mg Chiauranib po Only once with High Fat Diet
Drug: Chiauranib
50mg po only once
OTHER: Chiauranib(In the high fat diet state)
Experimental: Chiauranib Patients receive 50mg Chiauranib po only once with High Fat Diet and after 14 days receive 50mg Chiauranib po Only once In the fasting state
Drug: Chiauranib
50mg po only once

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
Measure Description
Time Frame
Pharmacokinetics of Chiauranib (in plasma)
Time Frame: up to 20 Days
Peak plasma concentration for Chiauranib(Cmax)
up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Time Frame: up to 20 Days
Area under the concentration-time curve from zero to last quantificable concentration for Chiauranib (AUC0-t)
up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Time Frame: up to 20 Days
Area under the concentration-time curve from zero extrapolated to infinity for Chiauranib（AUC0-inf）
up to 20 Days

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
Measure Description
Time Frame
Pharmacokinetics of Chiauranib (in plasma)
Time Frame: up to 20 Days
Time to Cmax for Chiaruanib（Tmax）
up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Time Frame: up to 20 Days
Elimination half-life（t1/2）
up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Time Frame: up to 20 Days
Apparent clearance（CL/F）
up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Time Frame: up to 20 Days
Apparent volume of distribution（Vd/F）
up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Time Frame: up to 20 Days
Elimination rate constant（λz）
up to 20 Days

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.
Chipscreen Biosciences, Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
H & J CRO International, Inc.

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.
June 2, 2022

Primary Completion (ACTUAL)

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.
June 28, 2022

Study Completion (ACTUAL)

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.
June 28, 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).
April 14, 2022

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.
April 21, 2022

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.
April 26, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

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.
February 9, 2023

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.
February 8, 2023

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.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • CAR 108

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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