NCT03486080

Study of Dutogliptin in Combination With Filgrastim in Post-Myocardial Infarction

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination With Filgrastim in Early Recovery Post-Myocardial Infarction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Recardio, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction

Detailed description

Dutogliptin 60 mg administered by twice daily subcutaneous (SC) injection for 14 days in combination with a fixed standard dose of filgrastim (10 µg/kg) administered SC daily for 5 days. This study will be conducted in adults with ST-elevation myocardial infarction (STEMI) with successful revascularization following percutaneous coronary intervention (PCI) and stent implantation. Primary Objective • To evaluate the safety and tolerability of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo Secondary Objectives * To assess preliminary efficacy of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo as determined by cardiac magnetic resonance imaging (cMRI) * To determine the pharmacokinetics (PK) of dutogliptin in a subset of the study population * To establish the pharmacodynamics (PD) of dutogliptin (plasma DPP4 activity) in a subset of the study population Exploratory Objectives * To examine the effects of dutogliptin in combination with filgrastim on: * Change from baseline in plasma stromal cell-derived factor (SDF)-1a levels * Change from baseline in plasma biomarkers, including N-terminal pro-b-type natriuretic peptide (NT-proBNP) and high sensitivity troponin

Conditions

• Acute Myocardial Infarction
• Acute Myocardial Ischemia
• STEMI - ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Dutogliptin Tartrate	Active treatment
DRUG	Filgrastim Injectable Product	Active treatment
DRUG	Placebos	placebo control

Timeline

• Start date: 2018-12-07
• Primary completion: 2021-02-26
• Completion: 2021-02-26
• First posted: 2018-04-03
• Last updated: 2021-05-27

Locations

12 sites across 5 countries: Austria, Belgium, Hungary, Netherlands, Poland

Regulatory

• FDA-regulated drug study