Phase 1 study to assess ADME after oral 14C labelled NKTR-118

• Research type

  Research Study

• Full title

  A Phase I, Open-Label, Single-Centre Study to Assess Absorption, Distribution, Metabolism and Excretion (ADME) after [14C]-labelled Oral Administration of NKTR-118 to Healthy Male Volunteers

• IRAS ID

  77725

• Sponsor organisation

  AstraZeneca

• Eudract number

  2011-000716-26

• ISRCTN Number

  xx

• Research summary

  NKTR-118 may be useful in the treatment of constipation in patients who take regular opioid painkillers (e.g. codeine). NKTR-118 blocks opioid receptors which are involved in this type of constipation, but should not block the pain relieving effect of opioids. We currently have very little information about how this drug is processed in the body, including how it is broken down and excreted. This study will aim to characterise the absorption, distribution, breakdown and excretion of the drug. As secondary outcomes, we will also be looking at the safety and tolerability of the same dose of drug and will identify its breakdown product in samples of urine, faeces and blood. We may also want to investigate how genetic variations may flunce the way subject responds to NKTR-118.The drug will be given with a radioactive label (at radiation levels well within acceptable safety limits) at a single dose of 25mg to 6 healthy male volunteers aged between 50 and 65 years.The study will take place at Quintiles Drug Research Unit at Guy's Hospital, Quintiles Ltd. There will be three visits. Visit one will involve screening safety assessments. Visit two will involve a single oral dose of the product as an oral solution (10mls). Volunteers will be discharged from the unit 240 hours after the dose. Visit three will consist of safety examinations. This study will be a Phase I, open label, non comparative, single-dose, single centre study. The information gained in this study will help the sponsor of this study to determine whether NKTR-118 is suitable for further studies to humans.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/0316

• Date of REC Opinion

  1 Jun 2011

• REC opinion

  Further Information Favourable Opinion