Pharmacokinetic StudyPhase 1NCT04804904
A Pharmacokinetic Study of TQB3101 in Chinese Healthy Subjects
A Phase 1 study testing TQ-B3101 in people with Pharmacokinetic Study, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
Evaluate the effect of food on the pharmacokinetics of TQB3101 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Study
- What is being tested?
- TQ-B3101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2021to 3 Jul 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be willing and able to give written informed consent by signing an IRB-approved Informed Consent Form prior to admission to this study;
- Subjects must be willing and able to communicate well, understand and follow the protocol required to complete the study;
- Males and females between 18 to 60 years of age
- Males and females with a body mass Index (BMI) range 19~26 kg/m2 inclusive, male subject not less than 50kg, female subject not less than 45kg。
- Male subjects must agree to use a medically acceptable method of contraception from Screening until 6 months after administration of the last dose of study drug
- Male subjects agrees not to donate sperm for at least 6 months after administration of the last dose of study drug
- Female subjects of non-childbearing potential measures, meeting at least one of the following criteria:①menorrhoeal for 12 months and FSH >40mIU/mL;② hysterectomy;③oophorectomy.
- Subjects who are healthy as determined by physical examination,vital signs, 12-Lead ECG and X-ray examination.
Who cannot join
- Subjects who have a history or presence of cardiovascular, neurological, endocrine, respiratory, hematological, immunological, psychiatric diseases or disorders that, could affect the conduct of the study or the absorption, metabolism or excretion of the study drug.
- Subjects who have a history of relevant drug hypersensitivity or atopic allergic disease history(asthma,urticaria, eczema dermatitis).
- Current or recent (within 6 months of study drug administration) gastrointestinal , liver and kidney disease that could impact upon the absorption of study drug.
- Any major surgery within 4 weeks of study drug administration .
- Subjects who consume more than 14 units of alcohol per week during 3 months before drug administration, taken any alcohol-containing products within 24 hours ,or subjects who test negative alcohol at screening and admission
- Smokers who smoked more than 5 cigarettes before study drug administration,or can not quit smoking during the study.
Show all 18Show fewer
- Subjects who test positive for drugs of abuse.
- Subjects who have donated blood or have a blood loss(≥300mL)within the previous 3 months prior to first dosing.
- Subjects who used any drugs that change liver enzyme activity,such as inhibitors or inducers of CYP3A4, P-gp or BCRP within 28days;
- Subjects who used any drugs including over thePrescription drugs, counter medications ,vitamin products herbal preparations.
- Subjects who have taken a special diet (including grapefruit, etc.) or exercised vigorously in the 14 days ,or other factors affecting drug absorption, distribution, metabolism, and excretion
- Participated in drug clinical trials within 3 months before taking the study ;
- Subjects with laboratory abnormalities,or or white blood cell count, neutrophil cell count and the percentage of the platelet count below the normal limit.
- Positive test result for HIV antibodies.
- Positive test for treponema Antibodies hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab).
- Subjects who have acute disease or concomitant medication at the time of screening and/or admission.
- Subjects who consuming chocolate, any caffeine-rich or xanthine-rich food or drink 24 hours before.
- The PI considered other factors unfit to participate.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: A Single Center, Phase I, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of TQB3101 in Healthy Subjects
Evaluate the effect of food on the pharmacokinetics of TQB3101 in healthy subjects.
- Conditions
- Pharmacokinetic Study
- Being tested
- TQ-B3101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ-B3101Drug
TQ-B3101 oral capsule
| Study group | Role | What they receive |
|---|---|---|
| TQ-B3101: Fed + Fast | Experimental | In each of the two study periods (separated by a washout period),a single dose of TQ-B3101 will be administered.Participants will receive TQ-B3101 in fed condition on Day 1 of treatment period 1 followed by a single oral dose of TQ-B3101 in fasted condition on Day 1 of treatment period 2. Receives: Drug: TQ-B3101 |
| TQ-B3101: Fast+Fed | Experimental | In each of the two study periods (separated by a washout period),a single dose of TQ-B3101 will be administered.Participants will receive TQ-B3101 in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of TQ-B3101 in fed condition on Day 1 of treatment period 2. Receives: Drug: TQ-B3101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum concentration of the analyte in plasma
Measured: pre-dosing on Day 1 up to 144 hours post-dosing
Tmax
Time to Reach the Maximum Observed Plasma Concentration (Cmax) of the analyte
Measured: pre-dosing on Day 1 up to 144 hours post-dosing
AUC0-t
Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration of the analyte
Measured: pre-dosing on Day 1 up to 144 hours post-dosing
AUC0-inf
Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time of the analyte
Measured: pre-dosing on Day 1 up to 144 hours post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start20 May 2021
- Primary completion15 Jun 2021
- Study completion3 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic StudyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
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
- NCT04804904
- Sponsor's protocol ID
- TQ-B3101-I-02
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Phase I, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of TQB3101 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04804904
- Acronym / sponsor ID
- TQ-B3101-I-02
- Conditions
- Pharmacokinetic Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 3 Jul 2021 (actual)
- First posted
- 18 Mar 2021 (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.
Evaluate the effect of food on the pharmacokinetics of TQB3101 in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQ-B3101: Fed + Fast | Experimental | Drug: TQ-B3101In each of the two study periods (separated by a washout period),a single dose of TQ-B3101 will be administered.Participants will receive TQ-B3101 in fed condition on Day 1 of treatment period 1 followed by a single oral dose of TQ-B3101 in fasted condition on Day 1 of treatment period 2. |
| TQ-B3101: Fast+Fed | Experimental | Drug: TQ-B3101In each of the two study periods (separated by a washout period),a single dose of TQ-B3101 will be administered.Participants will receive TQ-B3101 in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of TQ-B3101 in fed condition on Day 1 of treatment period 2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects must be willing and able to give written informed consent by signing an IRB-approved Informed Consent Form prior to admission to this study;
- Subjects must be willing and able to communicate well, understand and follow the protocol required to complete the study;
- Males and females between 18 to 60 years of age
- Males and females with a body mass Index (BMI) range 19~26 kg/m2 inclusive, male subject not less than 50kg, female subject not less than 45kg。
- Male subjects must agree to use a medically acceptable method of contraception from Screening until 6 months after administration of the last dose of study drug
Key exclusion criteria (18 listed)
- Subjects who have a history or presence of cardiovascular, neurological, endocrine, respiratory, hematological, immunological, psychiatric diseases or disorders that, could affect the conduct of the study or the absorption, metabolism or excretion of the study drug.
- Subjects who have a history of relevant drug hypersensitivity or atopic allergic disease history(asthma,urticaria, eczema dermatitis).
- Current or recent (within 6 months of study drug administration) gastrointestinal , liver and kidney disease that could impact upon the absorption of study drug.
- Any major surgery within 4 weeks of study drug administration .
- Subjects who consume more than 14 units of alcohol per week during 3 months before drug administration, taken any alcohol-containing products within 24 hours ,or subjects who test negative alcohol at screening and admission
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 |
|---|---|---|
| TQ-B3101TQ-B3101 oral capsule | Drug | TQ-B3101: Fast+Fed, TQ-B3101: Fed + Fast |
Primary outcome
Cmax
Time frame: pre-dosing on Day 1 up to 144 hours post-dosing
maximum concentration of the analyte in plasma
Tmax
Time frame: pre-dosing on Day 1 up to 144 hours post-dosing
Time to Reach the Maximum Observed Plasma Concentration (Cmax) of the analyte
AUC0-t
Time frame: pre-dosing on Day 1 up to 144 hours post-dosing
Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration of the analyte
AUC0-inf
Time frame: pre-dosing on Day 1 up to 144 hours post-dosing
Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time of the analyte
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 21 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 TQ-B3101 in people with Pharmacokinetic Study, 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 8 inclusion and 18 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 21 Jan 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?
Cmax (time frame: pre-dosing on Day 1 up to 144 hours post-dosing). The study lists 4 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 21 Jan 2022.