Evaluation of taste profiles of JNJ-64041575 formulations (QCL117802)

• Research type

  Research Study

• Full title

  A phase 1, double-blind, randomized study to assess the taste profile of different ALS-008176 oral liquid formulations in healthy adult subjects.

• IRAS ID

  207224

• Contact name

  Frank De Beukelaar

• Contact email

  fdbeukel@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2016-001517-24

• Clinicaltrials.gov Identifier

  NCT02813460

• Duration of Study in the UK

  0 years, 0 months, 28 days

• Research summary

  The Sponsor is developing the study drug, ALS-008176 (or JNJ-64041575)for the potential treatment of Respiratory syncytial virus (RSV). \n\nThe study will try to identify a formulation with an acceptable taste profile.\n\nThe study will consist of 2 sessions of 1 day involving up to 12 healthy male and females (non-child bearing potential) subjects. In session 1 subjects will assess 6 differently flavoured/sweetened formulations. In session 2 the two best scoring flavours will be tested with three varying levels of sucralose. The reference product will be a formulation containing 60 mg/mL of ALS-008176.

• REC name

  HSC REC A

• REC reference

  16/NI/0092

• Date of REC Opinion

  7 Jun 2016

• REC opinion

  Favourable Opinion