A FIH Healthy Volunteer Study of JNJ-48816274 (QCL114690)

• Research type

  Research Study

• Full title

  A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274

• IRAS ID

  192059

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2015-004186-89

• Duration of Study in the UK

  0 years, 5 months, 8 days

• Research summary

  Research Summary:
  The Sponsor is developing the study drug, JNJ-48816274 for the potential treatment of insomnia. The study has 2 planned parts and one optional part. Part 1 will take place at Quotient Clinical in Nottingham and will evaluate if the study drug is safe and well tolerated when given as a single dose to healthy males, females, with and without food and optionally to elderly (aged over 65) volunteers. How the body absorbs, distributes and gets rid of the study drug will also be assessed, as well as what effect the drug has on the body. Part 2 will assess the effect of the study drug on sleep when given at bedtime in a sleep clinic at the Surrey Clinical Research Centre. Part 3 is optional and will assess the effects of repeated daytime doses for 7 days.

  A total of 82 subjects are planned to be enrolled in this study. If optional cohorts and parts are included, a total of 160 subjects may be enrolled.

  Lay summary of study results:
  Given that this is a phase 1 trial, no lay summary of results has been provided for reasons of commercial confidentiality

• REC name

  Wales REC 1

• REC reference

  16/WA/0174

• Date of REC Opinion

  28 Jul 2016

• REC opinion

  Further Information Favourable Opinion