Healthy VolunteersPhase 1NCT05346601
Trial of Chiauranib Capsule on Pharmacokinetics to Assess the Effect of High Fat Diet in Healthy Volunteers
A Phase 1 study testing Chiauranib in people with Healthy Volunteers, run by Chipscreen Biosciences, Ltd. at 1 site in China.
Trial summary
The purpose of this study is to further study the pharmacokinetic characteristics of Chiauranib Capsule in Healthy Volunteers with High Fat Diet. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Chiauranib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2022to 28 Jun 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
- Ages: 18 Years to 45 Years
- 19≤BMI≤26. Weight of male ≥50 kg and Weight of female 45 kg
- 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)
- Healthy Volunteers have no plan to fertilize throughout treatment and for at least 6 months after study is stopped
- Healthy Volunteers voluntarily sign informed consent
- Able to communicate well with the Investigator, to comply with the requirements of the study
Who cannot join
- Has known allegies to Chiauranib ,any of the excipients or Have a history of relevant atopy or drug hypersensitivity
- 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
- Inability to take oral medication or having Gastrointestinal, liver and kidney diseases that affect drug absorption or metabolism within 6 months
- Prior to random Having uncured diarrhea or having 4 or more episodes of diarrhea within 7 days prior to scheduled drug administration
- Having any significant history of hemorrhagic disease or any history of coagulopathy
- 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；
Show all 24Show fewer
- Ccr < 80 mL/min
- Difficulty of venous blood collection
- QTcF > 450 ms
- Drug abuse within 5 years or used drug within 3 months prior to the study, or Urine drug screening is positive during screening
- 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
- Ingestion of prescription drugs, OTC drug, Vitamin, dietary supplements or herbal products within 14 days prior to screening
- 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
- 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
- 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
- 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
- The abnormal result of C-reactive protein has clinical significance or Subjects testing positive for COVID-19
- Vaccinated within 1 month prior to screening or plan to Vaccinate during the study
- Females with a positive pregnancy test or Women of childbearing potential, pregnant and lactating women
- Volunteer in any other study within 3 months prior to drug administration, or Volunteer in 3 times or more studies
- Blood donation or lost more than 400mL blood within 3 months prior to the study, or Received blood transfusions within 1 month
- Patients received major surgical operations within 6 months prior to screening, or plan to received surgical operation during the study
- Extremes in food consumption practices
- Other situations that the researchers considered unsuitable to enroll the subject
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 21500
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Chiauranib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChiauranibDrug
50mg po only once
| Study group | Role | What they receive |
|---|---|---|
| Chiauranib(In the fasting state) | Other | 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 Receives: Drug: Chiauranib |
| Chiauranib(In the high fat diet state) | Other | 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 Receives: Drug: Chiauranib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Chiauranib (in plasma)
Peak plasma concentration for Chiauranib(Cmax)
Measured: up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Area under the concentration-time curve from zero to last quantificable concentration for Chiauranib (AUC0-t)
Measured: up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Area under the concentration-time curve from zero extrapolated to infinity for Chiauranib（AUC0-inf）
Measured: up to 20 Days
Secondary outcomes (5)
Pharmacokinetics of Chiauranib (in plasma)
Time to Cmax for Chiaruanib（Tmax）
Measured: up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Elimination half-life（t1/2）
Measured: up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Apparent clearance（CL/F）
Measured: up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Apparent volume of distribution（Vd/F）
Measured: up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Elimination rate constant（λz）
Measured: up to 20 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start2 Jun 2022
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Chipscreen Biosciences, 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H & J CRO International, Inc.
- Responsible party
- Sponsor
- Investigators
- LiYan Miao, Principal investigator, First Affiliated Hospital of Suzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346601
- Sponsor's protocol ID
- CAR 108
- Status last verified
- Feb 2023
- First submitted
- 14 Apr 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05346601
- Acronym / sponsor ID
- CAR 108
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- H & J CRO International, Inc.
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 26 Apr 2022 (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.
The purpose of this study is to further study the pharmacokinetic characteristics of Chiauranib Capsule in Healthy Volunteers with High Fat Diet.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiauranib(In the fasting state) | Other | Drug: ChiauranibExperimental: 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 |
| Chiauranib(In the high fat diet state) | Other | Drug: ChiauranibExperimental: 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ages: 18 Years to 45 Years
- 19≤BMI≤26. Weight of male ≥50 kg and Weight of female 45 kg
- 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)
- Healthy Volunteers have no plan to fertilize throughout treatment and for at least 6 months after study is stopped
- Healthy Volunteers voluntarily sign informed consent
Key exclusion criteria (24 listed)
- Has known allegies to Chiauranib ,any of the excipients or Have a history of relevant atopy or drug hypersensitivity
- 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
- Inability to take oral medication or having Gastrointestinal, liver and kidney diseases that affect drug absorption or metabolism within 6 months
- Prior to random Having uncured diarrhea or having 4 or more episodes of diarrhea within 7 days prior to scheduled drug administration
- Having any significant history of hemorrhagic disease or any history of coagulopathy
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 |
|---|---|---|
| Chiauranib50mg po only once | Drug | Chiauranib(In the fasting state), Chiauranib(In the high fat diet state) |
Primary outcome
Pharmacokinetics of Chiauranib (in plasma)
Time frame: up to 20 Days
Peak plasma concentration for Chiauranib(Cmax)
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)
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）
5 secondary outcomes
Pharmacokinetics of Chiauranib (in plasma)
Time frame: up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Time frame: up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Time frame: up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Time frame: up to 20 Days
Pharmacokinetics of Chiauranib (in plasma)
Time frame: up to 20 Days
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 9 Feb 2023.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
LiYan Miao principal investigator
First Affiliated Hospital of Suzhou Medical College
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 Chiauranib in people with Healthy Volunteers, run by Chipscreen Biosciences, 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 24 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 9 Feb 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?
Pharmacokinetics of Chiauranib (in plasma) (time frame: up to 20 Days). 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 9 Feb 2023.