Advanced Malignant NeoplasmPhase 1NCT06165822
A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets
A Phase 1 study testing TQB3909 tablets, Itraconazole capsule and Rifampicin capsule in people with Advanced Malignant Neoplasm, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of Itraconazole Capsules/Rifampicin Capsules on pharmacokinetics of TQB3909 tablets in vivo, and the safety of TQB3909 tablets and combined with Itraconazole Capsules/Rifampicin Capsules after single oral dose. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Malignant Neoplasm
- What is being tested?
- TQB3909 tablets, Itraconazole capsule and Rifampicin capsule
- 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
- Dec 2023to Mar 2024
- 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
- At the time of signing the informed consent, males or females of between 18 and 45 years of age;
- Female weight ≥45 kg, male weight ≥50 kg, with a body mass index (BMI) between 19 and 26 kg/m2.
- Subjects in good health, as determined by a medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations;
- Subjects can comply with the study procedures, voluntarily participate in the study, and sign the informed consent in person.
Who cannot join
- Subjects: pre-existing or existing circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolic disorders mental diseases or abnormalities, or related chronic or acute diseases, which were not appropriate to participate in the trial as assessed by the investigators ;
- Subjects with systemic/local acute infection presented before study drug administration;
- Subjects who have a history of specific allergies, or allergies;
- Subjects who have difficulty in swallowing or have any gastrointestinal disorder that affects drug absorption at the time of screening；
- Subjects who cannot receive venous indwelling needle for blood sample collection；
- Subjects who cannot tolerate venous puncture or have a history of needle or blood sickness;
Show all 19Show fewer
- Subjects who drank regularly within the 6 months prior to the first dosing, such as those who drank more than 14 units of alcohol per week or who had a positive alcohol breath test at the time of screening；
- Subjects who had a history of major surgery, had taken the study drug, or had participated in other drug clinical trials within 3 months prior to the first dosing；
- Subjects who donated blood or lost significant amounts of blood within 3 months prior to the first dosing；
- Subjects who had used drugs within 3 months prior to the first dosing, or tested positive for drugs, or had a history of drug abuse within 5 years prior to screening；
- Subjects who smoked more than 5 cigarettes per day within the 3 months prior to the first dosing or who could not stop using any tobacco products during the trial；
- Subjects who consumed excessive amounts of tea, coffee, and/or caffeinated beverages daily within the 30 days prior to the first dosing；
- Subjects who have used any drug that inhibits or induces liver metabolism of the drug within the 30 days prior to the first dosing；
- Subjects who have taken any prescription, over-the-counter, herbal, or health product within the 14 days prior to the first dosing；
- Subjects who have taken a special diet or other factors affecting drug absorption, distribution, metabolism, or excretion within 7 days prior to the first dosing；
- Subjects who ingested chocolate, any caffeinated, or xanthine-rich food or drink within 48 hours before the first dosing；
- Subjects who have special dietary requirements and cannot follow a uniform diet；
- Female subjects of child-bearing potential；
- Subjects judged by the investigators to be unsuitable to participate.
Trial locations and contacts
1 site in 1 country.
China1 site
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213004
Fei Hua, MD, PhD, 0519-68870002, czyyphase1@163.com
Weiying Gu, MD, PhD, 0519-68871092, guweiying2001@163.com
About this study
Official title: A Phase I Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets
This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of Itraconazole Capsules/Rifampicin Capsules on pharmacokinetics of TQB3909 tablets in vivo, and the safety of TQB3909 tablets and combined with Itraconazole Capsules/Rifampicin Capsules after single oral dose.
- Conditions
- Advanced Malignant Neoplasm
- Being tested
- TQB3909 tablets, Itraconazole capsule, Rifampicin capsule
- Keywords
- Drug drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3909 tabletsDrug
TQB3909 100mg/tablet.
Itraconazole capsuleDrug
Itraconazole capsule is a strong inhibitor of CYP3A4.
Rifampicin capsuleDrug
Rifampicin capsule is a strong inducer of CYP3A4.
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole drug-durg interaction (DDI) | Experimental | Itraconazole capsules, 0.2g once daily from Day 3 to Day 10 TQB3909 tablets, single oral dose on Day 1 and Day 8. Receives: Drug: TQB3909 tablets; Drug: Itraconazole capsule |
| Rifampicin DDI | Experimental | Rifampicin capsule, 0.6g once daily from Day 3 to Day 11. TQB3909 tablets, single oral dose on Day 1 and Day 10. Receives: Drug: TQB3909 tablets; Drug: Rifampicin capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time to reach maximum (peak) plasma concentration following drug administration.
Measured: Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.
Maximum Plasma Concentration (Cmax)
The maximum observed plasma concentration of TQB3909
Measured: Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.
Elimination half-life (t1/2)
The time required for half of the drug to be eliminated from the plasma.
Measured: Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.
Secondary outcomes (1)
Incidence of adverse events (AEs)
Incidence of adverse events (AEs) based on the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Measured: Up to 12 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant NeoplasmStudies 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
- Non-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
- NCT06165822
- Sponsor's protocol ID
- TQB3909-I-02
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 12 Dec 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets
- ClinicalTrials.gov ID
- NCT06165822
- Acronym / sponsor ID
- TQB3909-I-02
- Conditions
- Advanced Malignant Neoplasm
- Keywords
- Drug drug interaction
- 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
- Dec 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 12 Dec 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 single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of Itraconazole Capsules/Rifampicin Capsules on pharmacokinetics of TQB3909 tablets in vivo, and the safety of TQB3909 tablets and combined with Itraconazole Capsules/Rifampicin Capsules after single oral dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itraconazole drug-durg interaction (DDI) | Experimental | Drug: TQB3909 tablets, Drug: Itraconazole capsuleItraconazole capsules, 0.2g once daily from Day 3 to Day 10 TQB3909 tablets, single oral dose on Day 1 and Day 8. |
| Rifampicin DDI | Experimental | Drug: TQB3909 tablets, Drug: Rifampicin capsuleRifampicin capsule, 0.6g once daily from Day 3 to Day 11. TQB3909 tablets, single oral dose on Day 1 and Day 10. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- At the time of signing the informed consent, males or females of between 18 and 45 years of age;
- Female weight ≥45 kg, male weight ≥50 kg, with a body mass index (BMI) between 19 and 26 kg/m2.
- Subjects in good health, as determined by a medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations;
- Subjects can comply with the study procedures, voluntarily participate in the study, and sign the informed consent in person.
Key exclusion criteria (19 listed)
- Subjects: pre-existing or existing circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolic disorders mental diseases or abnormalities, or related chronic or acute diseases, which were not appropriate to participate in the trial as assessed by the investigators ;
- Subjects with systemic/local acute infection presented before study drug administration;
- Subjects who have a history of specific allergies, or allergies;
- Subjects who have difficulty in swallowing or have any gastrointestinal disorder that affects drug absorption at the time of screening；
- Subjects who cannot receive venous indwelling needle for blood sample collection；
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 |
|---|---|---|
| TQB3909 tabletsTQB3909 100mg/tablet. | Drug | Itraconazole drug-durg interaction (DDI), Rifampicin DDI |
| Itraconazole capsuleItraconazole capsule is a strong inhibitor of CYP3A4. | Drug | Itraconazole drug-durg interaction (DDI) |
| Rifampicin capsuleRifampicin capsule is a strong inducer of CYP3A4. | Drug | Rifampicin DDI |
Primary outcome
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.
Time to reach maximum (peak) plasma concentration following drug administration.
Maximum Plasma Concentration (Cmax)
Time frame: Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.
The maximum observed plasma concentration of TQB3909
Elimination half-life (t1/2)
Time frame: Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.
The time required for half of the drug to be eliminated from the plasma.
1 secondary outcome
Incidence of adverse events (AEs)
Time frame: Up to 12 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
Related trials for Advanced Malignant Neoplasm
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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 TQB3909 tablets, Itraconazole capsule and Rifampicin capsule in people with Advanced Malignant Neoplasm, 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 4 inclusion and 19 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 12 Dec 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 Fei Hua, MD, PhD (0519-68870002, czyyphase1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Reach Maximum Observed Plasma Concentration (Tmax) (time frame: Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.). 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 12 Dec 2023.