Safety and Pharmacokinetics of JZP-386 in Healthy Subjects (QBR115223)

• Research type

  Research Study

• Full title

  A Double-Blind, Phase 1, Single-Center, Single-Ascending Dose Study of up to Four Dosing Regimens of JZP-386 Compared to Two Dosing Regimens of Xyrem® vs. Placebo to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics in Healthy Subjects

• IRAS ID

  146296

• Contact name

  Joanne Collier

• Contact email

  jo.collier@quotientclinical.com

• Sponsor organisation

  Concert Pharmaceuticals, Inc.

• Eudract number

  2013-004945-18

• ISRCTN Number

  to be entered

• Clinicaltrials.gov Identifier

  NCT02215499

• REC name

  Wales REC 1

• REC reference

  14/WA/0009

• Date of REC Opinion

  27 Jan 2014

• REC opinion

  Further Information Favourable Opinion