NCT05323136

Evaluate the Effects of Renal Impairment on the Pharmacokinetics and Pharmacodynamics

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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).

Detailed 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:

Conditions

• ACS - Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	MT1002 for Injection	single dose: 0.90 mg/kg initial loading dose (bolus intravenous injection) over 5 minutes + 1.8 mg/kg/hour (infusion) for 4 hours.

Timeline

• Start date: 2022-04-15
• Primary completion: 2022-06-29
• Completion: 2022-06-29
• First posted: 2022-04-12
• Last updated: 2023-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study