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
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.
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 →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.
Exclusion Criteria:
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
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
TQB3909 100mg/tablet.
Itraconazole capsule is a strong inhibitor of CYP3A4.
Rifampicin capsule is a strong inducer of CYP3A4.
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.
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.
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.
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.
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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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.