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

Status:	Recruiting
Conditions:	Constipation, Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	Any - 18
Updated:	12/20/2017
Start Date:	November 2014
End Date:	December 2018
Contact:	Kyowa Kirin Pharmaceutical Development, Ltd. KKD.D3820C00016
Email:	KKD.D3820C00016@kyowakirin.com
Phone:	00 44 1896 664 000

A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ≥ 6 Months to < 18 Years Receiving Treatment With Opioids

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

Main inclusion criteria, patient with:

- 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.

Main 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

We found this trial at

sites

Clinical Trial Facility in Stony Brook New York

Stony Brook, New York 11794

from

Stony Brook, NY