A Phase 1/2, Multicentre, Open-label Study to Evaluate thePharmacokinetics, Safety, and Tolerability of Naldemedine in PaediatricPatients Who Are Receiving or Who Are About to Receive Treatment with Opioids

Shionogi B.V.0 个研究点目标入组 32 人开始时间: 2020年2月3日最近更新: 2020年3月18日

研究概览

暂无简介。

•1. Patients = 6 months of age and < 18 years of age
•2. Patients receiving treatment or expected to receive treatment with an opioid for pain
•3. Have either newly diagnosed constipation, a history of constipation treated with laxatives, or expected to develop constipation after opioid treatment.
•4. Patients able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and able to return for blood sampling at the 24-hour timepoint.
•5. Patients able to comply with meal, tobacco, and concomitant medication restrictions
•6. BMI within approximately the 3rd to 97th percentile for their age according to the World Health Organization (WHO) Child Growth Standard
•7 a. Prepubescent male patients may participate. A postpubescent and sexually active male patient must agree to use appropriate contraception during the study and refrain from donating sperm during this period.
•7 b. A premenarchal female patient is eligible to participate. If a female patient is menarchal she must be not pregnant, not breastfeeding, and agree to follow appropriate contraceptive guidance during the treatment period and for at least 30 days after the last dose of naldemedine.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 32
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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
•3. Patients who have 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 hemodialysis
•8. Patients who have a history of hypersensitivity to naldemedine or any of its ingredients.
•9. Patients who have previously received naldemedine.
•10. Patients currently receiving their first cycle of chemotherapy
•11. 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
•12. Positive pregnancy test for female patients of childbearing potential

发起方