A study comparing PK of current version of Naloxegol to a new version

• Research type

  Research Study

• Full title

  A Phase I, Randomised, Open-label, 3 way Cross-over Study in Healthy Volunteers to Demonstrate the Bioequivalence of the Naloxegol 25 mg Commercial and Phase III Formulations and to Assess the Effect of Food Administration on the Pharmacokinetics of the Commercial Formulation

• IRAS ID

  107411

• Contact name

  Arpeat Kaviya

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2012-001531-31

• Research summary

  A well-tolerated and efficient treatment for constipation due to treatment with opioids (e.g morphine, codeine) remains a major unmet medical need for patients being treated for pain. Current treatment for opioid induced constipation (OIC) includes laxatives (e.g senna), stool softeners (e.g lactulose), and, if necessary, enemas. These are not optimal with only less than half of patients getting relief of symptoms. AstraZeneca is developing naloxegol (previously known as NKTR-118), a new treatment for constipation in patients receiving opioid therapy for pain. The current preparation of the naloxegel tablet which is being used in clinical trials is based on the naloxegol free base. AstraZeneca is now developing a new tablet formulation with slightly different additive contents and manufacturing method compared to the current preparation and this will be the preparation that they intend to market in the future. The purpose of this study is to compare the current tablet and the new tablet by measuring the levels of the drugs in blood after dosing. We will also look at the effect of food on the new tablet.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/0807

• Date of REC Opinion

  28 Jun 2012

• REC opinion

  Further Information Favourable Opinion