Safety, tolerability, PK, PD, and food effect of RO6953958

• Research type

  Research Study

• Full title

  A randomized, investigator- / subject-blind, single- and multiple-ascending dose, placebo-controlled study to investigate safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of RO6953958 following oral administration in healthy male participants. (19-020)

• IRAS ID

  276521

• Contact name

  Head, EU/International Regulatory Affairs

• Contact email

  welwyn.eudract@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche

• Eudract number

  2019-004486-41

• Duration of Study in the UK

  0 years, 10 months, 22 days

• Research summary

  Summary of Research
  The study medicine is an experimental new medicine for treating communication difficulties and sleep problems experienced by people with autism. Autism affects how people communicate and experience the world around them. Symptoms vary, but include difficulties in communicating and interacting with others, and showing repetitive patterns of behaviours. We hope that the study medicine will work by targeting areas of the brain that are linked to emotion and social behaviour.
  This is a 2-part study (Parts A and B), in healthy men, aged 18-55.
  Part A will include 2 groups of 8 participants (up to 16 volunteers). Each participant will have 4 study sessions, where they’ll receive a single dose of the medicine, by mouth. The study medicine has never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses.
  In Part B, we’ll test repeated doses of the study medicine in up to 5 groups of 8 participants (up to 40 volunteers). We’ll start with a low dose, and increase the dose as the study progresses.
  In both study parts, we aim to find out the side effects and blood levels of the study medicine. In Part A, we plan to also test if food affects blood levels of the study medicine.
  Participants will take up to 20 weeks to finish the study and have up to 4 study sessions, depending on the study part. They’ll stay on the ward for 3 nights in each study session (Part A); or 13 nights (Part B)as well as, 3–9 outpatient visits.
  A pharmaceutical company (F. Hoffmann-La Roche Ltd.) is funding the study.
  The study will take place at 1 centre in London.

  Summary of Results
  The lay summary of study results can be found at the following URL: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbSgv9uUS1wsd00iFWSZyptH89w1tcscJeKmImtXTgMdp4OWlJmztLxZKqrqBPAqhRxwfL-2Bon4-2FVUJsNG-2FjcPq1umb-2FPvW8lKK7YXFmUdR-2FXXheZGdggsiFxkGNKI3OQGaZBNNGUGkXSnYzeodCtI32ASjNHasGg7xQn-2FKlUvvCWdoaBBiYvrdQpTPFo6CprDpE5s382wBVLboucWkAJt7jk-3D3NWZ_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIissRL-2Beq2tf9-2B2R-2BLjcC0SCMiMy5TCfwStg6LHiEXW1rb9hBPjZ4cdj73LDmbiTwth-2BWUt48FqJ-2BAijCcFTarzrTqPkWts2zcY3yXN1Vm6DEfWvXKTYeSfvXtnIFsSj3qLdYiR6wY4GzLvjpxMFGlO4meTjFTUudfwRvC6H-2FVAg-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C3a371c680b784250e7f808db05f32547%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638110314077235381%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=XsuBqnPsWS3qJ3sHN36s8uzKLeKZvonTlbzBySG8nqA%3D&reserved=0

• REC name

  North East - York Research Ethics Committee

• REC reference

  20/NE/0038

• Date of REC Opinion

  10 Mar 2020

• REC opinion

  Further Information Favourable Opinion