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Evaluate the Effects of Renal Impairment on the Pharmacokinetics and Pharmacodynamics

ACS - Acute Coronary Syndrome Clinical Trial

Official title:
A Phase 1, Open-Label, Sequential, Adaptive, Single Dose Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics and Pharmacodynamics of MT1002 for Injection

Clinical Trial Summary

The study is a multicenter, Phase 1, open-label, sequential, adaptive, single dose, PK/PD study in subjects with moderate and severe RI and healthy volunteers (HV).

Clinical Trial Description

Because MT1002 for Injection is being developed for use as an anticoagulant and antiplatelet in patients with ACS and in patients undergoing PCI, these patients may have impaired RF, and it is important to evaluate whether exposure-response or exposure-safety relationship will be altered in RI. In addition, according to the FDA recommendations, a dedicated RI study including severe RI must be conducted. The study will be performed in 2 sequences, with interim safety, tolerability, PK, and PD review between both sequences: ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05323136
Study type Interventional
Source Shaanxi Micot Technology Limited Company
Contact
Status Terminated
Phase Phase 1
Start date April 15, 2022
Completion date June 29, 2022
View Details
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