NCT06598956

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

An Open, Parallel, Single-dose Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of TQ05105 Tablets in Patients With Different Levels of Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 17 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	TQ05105	TQ05105 is a Janus kinase (JAK) and Rho-associated coiled-coil-containing protein kinase (ROCK) inhibitors.

Timeline

• Start date: 2024-10-12
• Primary completion: 2025-03-17
• Completion: 2025-08-12
• First posted: 2024-09-19
• Last updated: 2025-08-24

Locations

1 site across 1 country: China