Opioid induced constipation MedDRA version: 24.0 Level: LLT Classification code 10071128 Term: Opioid induced constipation System Organ Class: 100000004856
Conditions
Sponsors
Shionogi B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients = 2 years of age and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with a history of a GI neoplasm or an ongoing GI-related issue or any recent (within last 1 year) or planned GI tract surgery 2. Patients with signs or symptoms of GI obstruction or patients with recurrent obstruction who may be at increased risk of GI perforation. 3. Patients who are unable to eat/swallow or have need of a nasogastric tube. 4. Patients who have reported no bowel movements for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (Study Day 1) 5. Patients with a history of more than 1 week of CTCAE Grade 3 neutropenia or thrombocytopenia with clinical sequelae 6. Patients who need mechanical ventilation 7. Patients who have severe CTCAE Grade 3 or above hepatic or renal impairment including end-stage renal disease requiring haemodialysis, as determined by the investigator 8. Patients that have any progressive neurological disorders or potential disruption to the blood-brain barrier (e.g., primary brain malignancies, CNS metastases, active multiple sclerosis, etc.) considering the risk of opioid withdrawal or reduced analgesia. 9. Patients who have a history of hypersensitivity to naldemedine or any of its ingredients. 10. Patients who have previously received naldemedine. 11. Patients currently receiving their first cycle of chemotherapy 12. Patients currently participating in another study of an investigational drug product or have received another investigational drug product within 30 days or 5 half-lives, whichever is longer, before baseline 13. Positive pregnancy test for female patients of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the pharmacokinetics, safety and tolerability of naldemedine in paediatric patients who are receiving or who are about to receive treatment with opioids;Timepoint(s) of evaluation of this end point: 7 days;Secondary Objective: To evaluate the safety and tolerability of naldemedine after a single oral dose of naldemedine in paediatric patients who are receiving or who are about to receive opioids. To evaluate the PK of naldemedine after multiple, once daily oral doses of naldemedine through population PK in paediatric patients who are receiving or who are about to receive opioids. To evaluate the palatability of naldemedine powder for oral suspension and the ability to swallow naldemedine tablets.;Primary end point(s): To evaluate the pharmacokinetics (PK) of naldemedine and nor-naldemedine after a single oral dose of naldemedine -- PK parameters using standard non-compartmental method, e.g. Cmax, Tmax, AUC, AUC0-last, AUC0-inf, ?z, t1/2,z of naldemedine and nor-naldemedine; and CL/F, MRT, and Vz/F for naldemedine only, and metabolic ratio of Cmax of nor-naldemedine to Cmax of naldemedine [MRM/U, Cmax] andmetabolic ratio of AUC of nor-naldemedine to AUC of naldemedine [MRM/U, AUC] for nor-naldemedine only | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the safety and tolerability of naldemedine after a single oral dose of naldemedine -- Using results of physical examinations (including assessment of opioid withdrawal symptoms and pain intensity), vital signs, 12-lead ECGs, safety laboratory tests, treatment-emergent adverse events (TEAEs), treatment-related TEAEs,including gastrointestinal (GI) events, and serious adverse events (SAEs) on Study Days 1 through 7 To evaluate the PK of naldemedine after multiple, once daily oral doses of naldemedine through population PK -- using Results of population PK analysis PK parameters using population PK analysis (e.g. Cmax, Tmax, AUC0-t, accumulation ratio for Cmax calculated as ratio of Day 7 to Day 1 Cmax (RCmax), and accumulation ratio for AUC calculated as ratio of Day 7 to Day 1 AUC (RAUC) for naldemedine only To evaluate the palatability of naldemedine powder for oral suspension and the ability to swallow naldemedine tablets --using results of self-reported visual analogue scale (VAS) for palatability assessments of naldemedine powder for oral suspension for patients = 6 years of age -- Results of investigator’s or patient’s parent/legal guardian assessment of palatability of naldemedine powder for oral suspension for patients = 2 years to < 6 years of age, and, if possible, patients’ self-assessment using a VAS with facial hedonic scale -- Results of self-reported ease of swallowing of naldemedine tablets ;Timepoint(s) of evaluation of this end point: To evaluate the safety and tolerability of naldemedine after a single oral dose of naldemedine: Days 1 through 7 To evaluate the PK of naldemedine after multiple, once daily oral doses of naldemedine through population PK: ratio of Day 7 to Day 1 To evaluate the palatability of naldemedine powder for oral suspension and the ability to swallow naldemedine tablets: during the study | — |
Countries
Belgium, France, Hungary, Italy, Netherlands, Serbia, Spain, United Kingdom
Contacts
Public ContactRegulatory Affairs Department
Shionogi B.V.
Outcome results
None listed