drugset / Trial / NCT06598956

To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Renal Impairment Subjects

NCT06598956

Phase 1 Completed 32 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with renal impairment after a single dose, and to evaluate the urinary excretion of the drug in these patients after a single dose, as well as to evaluate the safety of the drug in these patients after a single dose.

Timeline

Start
2024-10-12
Primary completion
2025-03-17
Completion
2025-08-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator TQ05105 Small molecule 5 mg Oral
Comparator TQ05105 Small molecule 10 mg Oral
Comparator TQ05105 Small molecule 15 mg Oral

Indications