Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

  • End date
    Nov 27, 2021
  • participants needed
  • sponsor
    Kyowa Kirin Pharmaceutical Development Ltd
Updated on 27 January 2021
Development Division Project Management Department
Primary Contact
Schneider Children Medical Center (6.6 mi away) Contact
+26 other location


To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.

Condition Constipation, Signs and Symptoms, Digestive, Constipation, Signs and Symptoms, Digestive, Constipation, Signs and Symptoms, Digestive, Constipation, Signs and Symptoms, Digestive, Constipation, Signs and Symptoms, Digestive, Constipation, Signs and Symptoms, Digestive, Constipation, Signs and Symptoms, Digestive
Treatment Naloxegol
Clinical Study IdentifierNCT02099591
SponsorKyowa Kirin Pharmaceutical Development Ltd
Last Modified on27 January 2021


Yes No Not Sure

Inclusion Criteria

malignant or non-malignant pain who are receiving or (are about to receive) acute or chronic treatment with opioids
newly diagnosed constatipation, with history of constipation treated with laxatives or expected to develop constipation after opioid treatment
ability to be present in the clinic for at least 10 hours following the first study drug for blood sampling and to return at 24 hours for blood sampling

Exclusion Criteria

Current acute or chronic use of methadone
History of an neoplasm or an ongoing gastrointestinal-related issue
Signs or symptoms of gastrointestinal obstruction
History of prolonged neutropenia or thrombocytopenia with clinical sequelae
Patients currently receiving the first cycle of chemotherapy
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