Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

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Description

The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.

Study Overview

Start Date
January 4, 2023
Completion Date
August 13, 2024
Enrollment
24
Date Posted
October 20, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Chu de Caen
Caen 14033, France

Eligibility

Minimum Age (years)
2
Maximum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Disease Characteristics

Participants with cancer or non-cancer pain who are receiving (or who are about to receive) acute or chronic treatment with opioids.
Participants with either newly diagnosed constipation, a history of constipation treated with laxatives, or are expected to develop constipation after opioid treatment.
Able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and are able to return for blood sampling at the 24-hour time point.

Weight

Body mass index within approximately the 3rd to 97th percentile for their age according to the World Health Organization Child Growth Standards.

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.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Contact Info

Study Contact Name
Shionogi Clinical Trials Administrator Clinical Support Help Line
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
NCTid (if applicable)
NCT05588323