Phase 1 Study of ALKS 7106 in Healthy Adult Men (QBR117346)

• Research type

  Research Study

• Full title

  A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 7106 in Healthy Adult Men

• IRAS ID

  156224

• Contact name

  Pui Man Leung

• Contact email

  pui.leung@quotientclinical.com

• Sponsor organisation

  Alkermes, Inc.

• Eudract number

  2014-001839-36

• Research summary

  The Sponsor is developing the study drug, ALKS 7106, for the potential treatment of acute pain, for example the type of pain patients may experience after surgery.

  The purpose of the study is to investigate how the study drug ALKS 7106 is taken up by the body when given as a capsule. The safety and tolerability of the study drug will also be assessed. This will be the first study of ALKS 7106 in humans. Nonclinical studies conducted to date support the safe use of ALKS 7106 in this clinical trial.

  The study will include 8 cohorts, with each cohort representing a different dose level. Each cohort will consist of 10 subjects randomised to receive ALKS 7106 or placebo. Subjects will be randomised to a single cohort only. ALKS 7106 will be provided as capsules in doses of between 3 and 150 milligram (mg), for a single oral administration. Placebo will consist of empty capsules identical in appearance to the ALKS 7106 capsules.

• REC name

  Wales REC 2

• REC reference

  14/WA/1014

• Date of REC Opinion

  24 Jun 2014

• REC opinion

  Favourable Opinion