ALK37-006

• Research type

  Research Study

• Full title

  A Phase 1 study to evaluate the pharmacokinetics and absolute oral bioavailability of RDC-1036

• IRAS ID

  91443

• Contact name

  Philip Evans

• Sponsor organisation

  Alkermes, Inc

• Eudract number

  2011-004649-41

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The Sponsor is developing RDC-1036 as a new potential treatment for opioid-induced constipation (OIC), meaning constipation which is a side effect of opioid pain medication. Opioids affect the gastrointestinal (GI) tract due to the presence of certain neuro-receptors, producing a common side effect of OIC. RDC-1036 is an opioid antagonist, meaning it blocks the receptor and prevents the effect of the opioid. It is functionally selective for certain opioid receptors, and it is predicted to be localised to the GI tract with limited effect on the Central Nervous System (CNS). This means that it could prove an effective treatment for persons taking opioid pain medication which acts in the CNS and has unwanted side effects in the GI tract.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  11/EE/0454

• Date of REC Opinion

  2 Dec 2011

• REC opinion

  Further Information Favourable Opinion