NCT05344729

Clinical Trial for Effect of TQB3616 Capsule on Pharmacokinetics in Healthy Adult Subjects

A Randomized, Open-label, Single-center, Two-period, Two-crossover Phase I Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of TQB3616 Capsules in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

TQB3616 capsule is a small molecule oral drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., which inhibits cyclin-dependent kinases 4 and 6 (CDK4/6). Its main mechanism of action is to inhibit the proliferation of tumor cells by reducing the phosphorylation level of retinoblastoma protein (Rb) in cancer cells and blocking the progression of cells from G1 phase to S phase. This study is a randomized, open-label, single-center, two-period, two-crossover phase I clinical trial to assess the effect of food on the pharmacokinetics of TQB3616 capsules in healthy adult subjects, to evaluate the effect of food on the pharmacokinetics of TQB3616 capsules after oral administration in healthy adult Chinese subjects and to observe the safety of TQB3616 capsules after single oral administration in healthy subjects.Each subject will be randomly assigned to one of two groups (group A and B). A total of 16 subjects were enrolled, all taking TQB3616 capsules 180mg, including 8 subjects in group A and 8 subjects in group B. The study included screening period, randomization, first cycle, washout period and second cycle. The first cycle and second cycle each contained 3 return visits. 18 pharmacokinetic samples were collected every cycle for pharmacokinetic index analysis. Vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests, adverse events, drug combination and non-drug therapy information were collected during the study to ensure the safety of the subjects.

Conditions

• Recurrent/Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	TQB3616 Capsule	It inhibits the proliferation of tumor cells by reducing the level of retinoblastoma protein (Rb) phosphorylation in cancer cells and blocking the progression of cells from G1 to S phase.

Timeline

• Start date: 2021-07-06
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2022-04-25
• Last updated: 2022-04-25

Locations

1 site across 1 country: China