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