drugset
drugset / Trial / NCT02099591

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

NCT02099591 ↗

Phase 1 Completed 61 enrolled Kyowa Kirin Pharmaceutical Development Ltd
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2014-11
Primary completion
2021-04
Completion
2021-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxegol Small molecule 12.5 mg Oral
Subject Naloxegol Small molecule 25 mg Oral

Indications

constipation disorder