Study identifier:D3820C00016
ClinicalTrials.gov identifier:NCT02099591
EudraCT identifier:2013-003935-32
CTIS identifier:N/A
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
Constipation, Signs and Symptoms, Digestive
Phase 1
No
Naloxegol
All
48
Interventional
6 Months - 18 Years
Allocation: N/A
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Dec 2016 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Age group: > = 12y to < 18y - Lower dose | Drug: Naloxegol 8 new evaluable patients within the same age group, given a dose of Naloxegol, peripherally acting opioid antagonist, equivalent to 12.5 mg adult dose and continue for up to 6 months. Approval of the Safety Pharmacokinetic Review Committee to enrol new patients for the higher dose group will be based on data obtained from at least 8 evaluable patients (patients who contribute enough data for calculating AUC of naloxegol on Day 1 without important protocol deviations or violations thought to significantly affect the PK of the drug) for up to 2 weeks of treatment with naloxegol. For any or all of those patients, if data obtained is from less than 2 weeks of treatment, then the Safety Pharmacokinetic Review Committee evaluation and approval will be based on whatever data is available. |
Experimental: Age group: > = 12y to < 18y - Higher dose | Drug: Naloxegol 8 new evaluable patients within the same age group, given a dose of Naloxegol, peripherally acting opioid antagonist, equivalent to 25 mg adult dose and continue for up to 6 months. Approval of the Safety Pharmacokinetic Review Committee to enrol new patients for the higher dose group will be based on data obtained from at least 8 evaluable patients (patients who contribute enough data for calculating AUC of naloxegol on Day 1 without important protocol deviations or violations thought to significantly affect the PK of the drug) for up to 2 weeks of treatment with naloxegol. For any or all of those patients, if data obtained is from less than 2 weeks of treatment, then the Safety Pharmacokinetic Review Committee evaluation and approval will be based on whatever data is available. |
Experimental: Age group: > = 6y to < 12y - Lower dose | Drug: Naloxegol 8 new evaluable patients within the same age group, given a dose of Naloxegol, peripherally acting opioid antagonist, equivalent to 12.5 mg adult dose and continue for up to 6 months. Approval of the Safety Pharmacokinetic Review Committee to enrol new patients for the higher dose group will be based on data obtained from at least 8 evaluable patients (patients who contribute enough data for calculating AUC of naloxegol on Day 1 without important protocol deviations or violations thought to significantly affect the PK of the drug) for up to 2 weeks of treatment with naloxegol. For any or all of those patients, if data obtained is from less than 2 weeks of treatment, then the Safety Pharmacokinetic Review Committee evaluation and approval will be based on whatever data is available. |
Experimental: Age group: > = 6y to < 12y - Higher dose | Drug: Naloxegol 8 new evaluable patients within the same age group, given a dose of Naloxegol, peripherally acting opioid antagonist, equivalent to 25 mg adult dose and continue for up to 6 months. Approval of the Safety Pharmacokinetic Review Committee to enrol new patients for the higher dose group will be based on data obtained from at least 8 evaluable patients (patients who contribute enough data for calculating AUC of naloxegol on Day 1 without important protocol deviations or violations thought to significantly affect the PK of the drug) for up to 2 weeks of treatment with naloxegol. For any or all of those patients, if data obtained is from less than 2 weeks of treatment, then the Safety Pharmacokinetic Review Committee evaluation and approval will be based on whatever data is available. |
Experimental: Age group: > = 6mo to < 6y - Lower dose | Drug: Naloxegol 8 new evaluable patients within the same age group, given a dose of Naloxegol, peripherally acting opioid antagonist, equivalent to 12.5 mg adult dose and continue for up to 6 months. Approval of the Safety Pharmacokinetic Review Committee to enrol new patients for the higher dose group will be based on data obtained from at least 8 evaluable patients (patients who contribute enough data for calculating AUC of naloxegol on Day 1 without important protocol deviations or violations thought to significantly affect the PK of the drug) for up to 2 weeks of treatment with naloxegol. For any or all of those patients, if data obtained is from less than 2 weeks of treatment, then the Safety Pharmacokinetic Review Committee evaluation and approval will be based on whatever data is available. |
Experimental: Age group: > = 6mo to < 6y - Higher dose | Drug: Naloxegol 8 new evaluable patients within the same age group, given a dose of Naloxegol, peripherally acting opioid antagonist, equivalent to 25 mg adult dose and continue for up to 6 months. Approval of the Safety Pharmacokinetic Review Committee to enrol new patients for the higher dose group will be based on data obtained from at least 8 evaluable patients (patients who contribute enough data for calculating AUC of naloxegol on Day 1 without important protocol deviations or violations thought to significantly affect the PK of the drug) for up to 2 weeks of treatment with naloxegol. For any or all of those patients, if data obtained is from less than 2 weeks of treatment, then the Safety Pharmacokinetic Review Committee evaluation and approval will be based on whatever data is available. |