A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance

A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance

This study is being conducted to evaluate the safety, tolerability and early efficacy of IV TD 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are admitted to the intensive care require mechanical ventilation, and are intolerant to enteral feeding.

Inclusion Criteria:

• Intubated, on mechanical ventilation, and anticipated to remain on mechanical ventilation for 2 days after enrollment into the study
• Receiving enteral feeding and assessed to have developed EFI, as defined by a GRV measurement ≥250 mL within the 24 hours before randomization

Exclusion Criteria:

• History of diabetic or idiopathic gastroparesis
• Screening blood glucose >15 mmol/L (270 mg/dL) while receiving insulin
• Impaired renal function, as defined by estimated glomerular filtration rate (eGFR) <30 mL/min, as determined by the Cockcroft-Gault formula -Bilirubin concentration in blood >2 times the upper limit of normal
• ALT or AST >3 times upper limit of normal
• Alkaline phosphatase >2 times upper limit of normal
• Contraindication to enteral feeding
• Opioid or other drug overdose as the primary reason for admission to Intensive Care Unit (ICU)
• Receipt of a drug that can be used as a gastric prokinetic agent
• Receipt of agents known to directly influence the 5 HT4/acetylcholine prokinetic mechanism