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

Kyowa Kirin

Status and phase: Completed; Phase 1

Conditions: Constipation, Signs and Symptoms, Digestive

Treatments: Drug: Naloxegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02099591

D3820C00016

UTN: U1111-1154-5575 (Other Identifier)

2013-003935-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 6 patient groups

Age group: > = 12y to < 18y - Lower dose

Experimental group

Description:

Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.

Treatment:

Drug: Naloxegol

Age group: > = 12y to < 18y - Higher dose

Experimental group

Description:

Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.

Treatment:

Drug: Naloxegol

Age group: > = 6y to < 12y - Lower dose

Experimental group

Description:

Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.

Treatment:

Drug: Naloxegol

Age group: > = 6y to < 12y - Higher dose

Experimental group

Description:

Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.

Treatment:

Drug: Naloxegol

Age group: > = 6mo to < 6y - Lower dose

Experimental group

Description:

Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.

Treatment:

Drug: Naloxegol

Age group: > = 6mo to < 6y - Higher dose

Experimental group

Description:

Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.

Treatment:

Drug: Naloxegol