Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO).

Exclusion Criteria

• •Subjects with primary CIPO or CIPO secondary to other known endocrine/metabolic, autoimmune diseases and neurologic conditions other than neurodegenerative or demyelinating diseases.
• •Subjects with conditions characterized by mechanical intestinal obstruction.
• •Nasogastric tube, gastrostomy tube, or jejunostomy feeding tube in place at randomization or planned throughout the duration of the study, or artificial food need scale stage 3.
• •Presence of untreated clinically relevant thyroid dysfunction or known thyroid dysfunction not well controlled by treatment deemed clinically significant by the Investigator.
• •Subjects with history of diabetes at screening.
• •Clinically significant ECG abnormalities at screening and randomization.
• •Screening ECG with a QTcF \>450 msec in males or \>470 msec in females or family history of sudden cardiac death.
• •Subjects requiring a low galactose diet.
• •Hypersensitivity or documented intolerance to lactulose, lactose or any excipient of the lactulose preparation to be used for L-BT.
• •History of sensitivity to velusetrag, or any of the velusetrag or placebo excipients.
• •Use of scopolamine or erythromycin within 2 weeks prior to screening and/or planned throughout the duration of the study.
• •Use of 5-HT4 receptor agonists within 5 days prior to randomization and/or planned throughout the duration of the study
• •Use of opioids within 8 weeks from screening and/or planned throughout the duration of the study.
• •Received strong cytochrome P450-isozyme 3A4 (CYP3A4) inhibitors within 2 weeks prior to screening and/or planned throughout the duration of the study.
• •Received strong P-glycoprotein (P-gp) transporter inhibitors within 2 weeks prior to Screening and/or planned throughout the duration of the study.
• •Received strong breast cancer resistance protein transporter inhibitors within 2 weeks prior to screening and/or planned throughout the duration of the study.
• •Current swab-positive or suspected (under investigation) COVID-19 infection.
• •Cancer (excluding non-melanoma skin cancer) and/or need of any anti-cancer treatment (also including radiotherapy) within the last 5 years.
• •Severe kidney impairment.
• •Aspartate aminotransferase (AST) or alanine transaminase (ALT) levels \>2.5 times the upper limit of normal (ULN); bilirubin (unless deemed to be due to Gilbert's Syndrome) or alkaline phosphatase (ALP) \>1.5 times ULN.
• •Severe hepatic impairment defined as Child-Pugh C.
• •History of any of the following cardiac disorders: i) torsade de pointes, ventricular tachycardia, ventricular fibrillation; ii) previous myocardial infarction, unstable angina pectoris, acute coronary syndrome, coronary artery or cerebral revascularization procedure or stroke within the previous 18 months; iii) angina pectoris class 2-4 during the last 12 months prior to screening; iv) congestive heart failure NYHA class III-IV during the last 18 months prior to screening.
• •History of any alcohol or drug abuse or dependence within the last year (Investigator's judgement).
• •Any current significant health condition that in the Investigator's judgement may: i) jeopardize the patient's safe participation in the trial or ii) make unlikely the patient's completion of the study or iii) make unlikely the patient's compliance with the study procedures.
• •Pregnant or breastfeeding woman.
• •Use of any experimental drug within 12 weeks prior to screening