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

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