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Not yet recruitingNCT06165822Updated Dec 12, 2023

A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets

A Phase 1 interventional study of TQB3909 tablets and Itraconazole capsule in Advanced Malignant Neoplasm, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Malignant Neoplasm

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Keywords

  • Drug drug interaction
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Itraconazole drug-durg interaction (DDI)

    Itraconazole capsules, 0.2g once daily from Day 3 to Day 10 TQB3909 tablets, single oral dose on Day 1 and Day 8.

    Drug: TQB3909 tablets · Drug: Itraconazole capsule

  • Experimental
    Rifampicin DDI

    Rifampicin capsule, 0.6g once daily from Day 3 to Day 11. TQB3909 tablets, single oral dose on Day 1 and Day 10.

    Drug: TQB3909 tablets · Drug: Rifampicin capsule

Interventions

  • DrugTQB3909 tablets

    TQB3909 100mg/tablet.

  • DrugItraconazole capsule

    Itraconazole capsule is a strong inhibitor of CYP3A4.

  • DrugRifampicin capsule

    Rifampicin capsule is a strong inducer of CYP3A4.

06

What researchers measure

Primary outcomes

  1. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time to reach maximum (peak) plasma concentration following drug administration.

    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.

  2. Maximum Plasma Concentration (Cmax)

    The maximum observed plasma concentration of TQB3909

    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.

  3. Elimination half-life (t1/2)

    The time required for half of the drug to be eliminated from the plasma.

    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.

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

    Time frame: Up to 12 days.

07

Study locations

1 site
  • The First People's Hospital of Changzhou
    Changzhou, Jiangsu 213004, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06165822
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Dec 12, 2023
Start date
Dec 2023 (estimated)
Primary completion
Jan 2024 (estimated)
Completion
Mar 2024 (estimated)
Last update
Dec 12, 2023

Study contacts

Fei Hua, MD, PhD
Contact
czyyphase1@163.com
0519-68870002
Weiying Gu, MD, PhD
Contact
guweiying2001@163.com
0519-68871092

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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