Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients - KODIAK16
Study identifier:D3820C00016
ClinicalTrials.gov identifier:NCT02099591
EudraCT identifier:2013-003935-32
CTIS identifier:N/A
Recruiting
Official Title
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
Medical condition
Constipation, Signs and Symptoms, Digestive
Phase
Phase 1
Healthy volunteers
No
Study drug
Naloxegol
Sex
All
Estimated Enrollment
48
Study type
Interventional
Age
6 Months - 18 Years
Date
Study Start Date: 01 Nov 2014
Estimated Primary Completion Date: 01 Nov 2017
Estimated Study Completion Date: 01 Nov 2017
Study design
Allocation: N/A
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| 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. |
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