Biliary CarcinomaPhase 1NCT06139367
A Clinical Trial of TQB3454 Tablets in Healthy Adult Subjects
A Phase 1 study testing TQB3454 tablets in people with Biliary Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, open, parallel, single center phase I clinical trial to evaluate the impact of food on the pharmacokinetics of TQB3454 tablets in healthy adult subjects. The aim is to evaluate the impact of food on the pharmacokinetics as well as the safety after single dose of TQB3454 tablets taken orally by… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Biliary Carcinoma
- What is being tested?
- TQB3454 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Nov 2023to Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the study;
- Able to complete the study according to the requirements of the protocol;
- Subjects aged 18-65 (inclusive);
- Body mass index (BMI) ≥ 18 and ≤ 28 kg/m^2, and male's weight ≥ 50 kg and female's weight ≥ 45 kg;
- Health status: No mental abnormalities, no history of severe neurological, respiratory, digestive, urinary, endocrine, and metabolic abnormalities;
- The subjects have no pregnancy plan, voluntarily take effective contraceptive measures, and no plans to donate sperm or eggs, from the date of signing the inform consent (14 days before signing the inform consent for female subjects) to at least 6 months after the last administration.
Who cannot join
- Subjects with allergic constitution or a history of allergies to two or more foods or drugs;
- Subjects who have experienced arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism;
- Suffering from ≥ Level 2 myocardial ischemia or infarction, arrhythmia (including QTc ≥ 450 ms for male, QTc ≥ 470 ms for female), and ≥ Level 2 congestive heart failure (New York Heart Association (NYHA) classification);
- Those with multiple factors that affect oral medication (such as inability to swallow, gastrointestinal diseases);
- Have taken any prescription, over-the-counter, vitamin product, or herbal medicine within one month before the first administration;
- Take CYP3A4 inhibitors or inducers within one month before the first administration or before the study medication;
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- Those who have taken a special diet (including grapefruit, etc.) or engaged in vigorous exercise within 14 days before the first administration or have other factors that affect drug absorption, distribution, metabolism, excretion, etc.;
- Abnormal and clinically significant physical examination, vital signs, electrocardiogram, and laboratory tests during the screening period;
- Donated blood or experienced significant blood loss (>450 mL) within 3 months prior to taking the study drug;
- Participated in any clinical trial and took any investigational drug within 3 months prior to taking the study drug;
- Smoke at least 5 cigarettes per day within 3 months prior to the study;
- Positive alcohol breath test or history of alcoholism within 2 weeks prior to screening (drinking 14 units of alcohol per week: 1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine);
- Drug screening positive or those who have used drugs in the past 3 months prior to the study;
- Inability to tolerate venous puncture for blood collection or poor vascular condition;
- The subject is unable to complete the experiment due to personal reasons;
- Other conditions that it is considered not suitable for enrollment assessed by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 400010
Yu Cao, Master of Medicine, 18661809090, caoyu1767@126.com
About this study
Official title: A Randomized, Open, Parallel, Single Center Phase I Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of TQB3454 Tablets in Healthy Adult Subjects.
This is a randomized, open, parallel, single center phase I clinical trial to evaluate the impact of food on the pharmacokinetics of TQB3454 tablets in healthy adult subjects. The aim is to evaluate the impact of food on the pharmacokinetics as well as the safety after single dose of TQB3454 tablets taken orally by Chinese healthy adult subjects, with pharmacokinetic indicators as the primary endpoint.
- Conditions
- Biliary Carcinoma
- Being tested
- TQB3454 tablets
- Keywords
- Food effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3454 tabletsDrug
TQB3454 is a Isocitrate dehydrogenase 1 (IDH1) mutation inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| TQB3454 tablets under fast condition | Experimental | TQB3454 tablets 600mg, take one dose orally under fast condition. Receives: Drug: TQB3454 tablets |
| TQB3454 tablets under fed condition | Experimental | TQB3454 tablets 600mg, take one dose orally under fed condition. Receives: Drug: TQB3454 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
Maximum plasma drug concentration
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Area under the time-concentration curve from 0 to t hours (AUC0-t)
Area under the plasma concentration-time curve from the time of first dose to the time of the last measurable concentration.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Area under the time-concentration curve from 0 to infinity (AUC0-∞)
Area under the plasma concentration-time curve from the time of first dose extrapolated to infinity
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Time to peak (Tmax)
Time to reach maximum plasma concentration after drug administration
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Elimination half-life (t1/2)
The time it takes for the blood concentration of a drug to decrease from its highest value to half in the body.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Apparent volume of distribution (Vd/F)
The ratio of the amount of drug in the body to the concentration in the blood.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Apparent clearance (CL/F)
Apparent total clearance of the drug from plasma after oral administration.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Elimination rate constant (λz)
Terminal disposition rate constant/terminal rate constant
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Lag time (tlag)
The time required from the start of administration to the appearance of the drug in the blood.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Percentage of residual area (AUC% Extrap)
Residual area as a percentage of the entire area under curve.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Secondary outcomes (2)
Adverse event rate
The incidence of adverse events (AEs), abnormal laboratory test values, and severe adverse events (SAEs).
Measured: Before the first administration to 360 hours after the last administration.
Adverse event severity
The severity of adverse events (AEs), abnormal laboratory test values, and severe adverse events (SAEs).
Measured: Before the first administration to 360 hours after the last administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary CarcinomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139367
- Sponsor's protocol ID
- TQB3454-I-03
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Parallel, Single Center Phase I Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of TQB3454 Tablets in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT06139367
- Acronym / sponsor ID
- TQB3454-I-03
- Conditions
- Biliary Carcinoma
- Keywords
- Food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Nov 2023 (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.
This is a randomized, open, parallel, single center phase I clinical trial to evaluate the impact of food on the pharmacokinetics of TQB3454 tablets in healthy adult subjects. The aim is to evaluate the impact of food on the pharmacokinetics as well as the safety after single dose of TQB3454 tablets taken orally by Chinese healthy adult subjects, with pharmacokinetic indicators as the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB3454 tablets under fast condition | Experimental | Drug: TQB3454 tabletsTQB3454 tablets 600mg, take one dose orally under fast condition. |
| TQB3454 tablets under fed condition | Experimental | Drug: TQB3454 tabletsTQB3454 tablets 600mg, take one dose orally under fed condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the study;
- Able to complete the study according to the requirements of the protocol;
- Subjects aged 18-65 (inclusive);
- Body mass index (BMI) ≥ 18 and ≤ 28 kg/m^2, and male's weight ≥ 50 kg and female's weight ≥ 45 kg;
- Health status: No mental abnormalities, no history of severe neurological, respiratory, digestive, urinary, endocrine, and metabolic abnormalities;
Key exclusion criteria (16 listed)
- Subjects with allergic constitution or a history of allergies to two or more foods or drugs;
- Subjects who have experienced arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism;
- Suffering from ≥ Level 2 myocardial ischemia or infarction, arrhythmia (including QTc ≥ 450 ms for male, QTc ≥ 470 ms for female), and ≥ Level 2 congestive heart failure (New York Heart Association (NYHA) classification);
- Those with multiple factors that affect oral medication (such as inability to swallow, gastrointestinal diseases);
- Have taken any prescription, over-the-counter, vitamin product, or herbal medicine within one month before the first administration;
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 |
|---|---|---|
| TQB3454 tabletsTQB3454 is a Isocitrate dehydrogenase 1 (IDH1) mutation inhibitor. | Drug | TQB3454 tablets under fast condition, TQB3454 tablets under fed condition |
Primary outcome
Peak concentration (Cmax)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Maximum plasma drug concentration
Area under the time-concentration curve from 0 to t hours (AUC0-t)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Area under the plasma concentration-time curve from the time of first dose to the time of the last measurable concentration.
Area under the time-concentration curve from 0 to infinity (AUC0-∞)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Area under the plasma concentration-time curve from the time of first dose extrapolated to infinity
Time to peak (Tmax)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Time to reach maximum plasma concentration after drug administration
Elimination half-life (t1/2)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
The time it takes for the blood concentration of a drug to decrease from its highest value to half in the body.
Apparent volume of distribution (Vd/F)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
The ratio of the amount of drug in the body to the concentration in the blood.
Apparent clearance (CL/F)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Apparent total clearance of the drug from plasma after oral administration.
Elimination rate constant (λz)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Terminal disposition rate constant/terminal rate constant
Lag time (tlag)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
The time required from the start of administration to the appearance of the drug in the blood.
Percentage of residual area (AUC% Extrap)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Residual area as a percentage of the entire area under curve.
2 secondary outcomes
Adverse event rate
Time frame: Before the first administration to 360 hours after the last administration.
Adverse event severity
Time frame: Before the first administration to 360 hours after the last administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
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 TQB3454 tablets in people with Biliary Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group 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 16 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: status not confirmed, as of the sponsor's last update on 18 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao, Master of Medicine (18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak concentration (Cmax) (time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.). The study lists 10 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 18 Nov 2023.