Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

Exclusion Criteria

• •Medical Conditions
• •History of a gastrointestinal (GI) neoplasm or an ongoing GI-related issue or any recent (within last 1 year) or planned GI tract surgery.
• •Signs or symptoms of GI obstruction or participants with recurrent obstruction who may be at increased risk of GI perforation.
• •Inability to eat/swallow or have need of a nasogastric tube.
• •No bowel movements reported for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (Study Day 1).
• •History of more than 1 week of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 neutropenia or thrombocytopenia with clinical sequelae.
• •Participants who need mechanical ventilation.
• •Severe CTCAE Grade 3 or above hepatic or renal impairment including end-stage renal disease requiring hemodialysis, as determined by the investigator.
• •Progressive neurological disorders or potential disruption to the blood-brain barrier (for example, primary brain malignancies, central nervous system metastases, active multiple sclerosis, etc.) considering the risk of opioid withdrawal or reduced analgesia.
• •Prior/Ongoing Medications
• •Currently receiving the first cycle of chemotherapy.
• •Previously received naldemedine.
• •Other Exclusions
• •\- Positive pregnancy test for females of childbearing potential.