SAD/MAD study of Z944-20-MR7 tablet in healthy adults (QCL117836)

• Research type

  Research Study

• Full title

  Double-Blind, Placebo-Controlled, Randomized Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses of a Modified-Release Tablet Formulation of Z944 in Healthy Adult Volunteers

• IRAS ID

  217881

• Contact name

  Margaret S. Lee

• Contact email

  margaret.lee@taro.com

• Sponsor organisation

  Taro Pharmaceuticals, Inc.

• Eudract number

  2016-004337-24

• Duration of Study in the UK

  0 years, 3 months, 22 days

• Research summary

  The Sponsor is developing the drug, Z944, for the potential treatment of pain. In order to aid the development of Z944 this study will be investigating the study drug Z944-20-MR7.\n\nThe study will try to identify the safety and how well tolerated singles doses and multiple doses of the study drug are when given at different dose levels in healthy subjects.\n\nThe study will consist of two parts involving up to 50 healthy male and female (not of childbearing potential) subjects. In Part A, up to 30 subjects will receive a dose of either 20, 40, 60 mg of study drug or matching placebo (Z944-PBO-MR). In Part B, up to 20 subjects will receive a dose ranging between 20 and 60 mg of study drug or Z944-PBO-MR. Samples of blood will be taken throughout the study to look at the concentration of the drug in the body. \n

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  16/LO/2204

• Date of REC Opinion

  4 Jan 2017

• REC opinion

  Further Information Favourable Opinion