Phase I PK study of multiple VH4004280 formulations (QSC300612)

• Research type

  Research Study

• Full title

  A 2-part, Phase 1, single-center, open-label study to assess the relative bioavailability of oral formulations for an investigational capsid inhibitor in healthy adult participants, and to evaluate the effect of food on bioavailability for an investigational capsid inhibitor in healthy adult participants

• IRAS ID

  1008416

• Contact name

  Karen Grainger

• Contact email

  karen.m.grainger@viivhealthcare.com

• Sponsor organisation

  ViiV Healthcare UK Limited

• Clinicaltrials.gov Identifier

  NCT06168318

• Research summary

  The Sponsor is developing the test medicine, VH4004280, as a potential treatment for Human Immunodeficiency Virus type 1 (HIV-1). HIV-1 is a virus that damages the cells in the immune system and weakens the immune system’s ability to fight off infections and diseases.

  In this study, healthy volunteers will be given different forms of the test medicine in single oral doses.
  We aim to answer these questions.
  * How much test medicine enters the bloodstream and how quickly does the body get rid of it?
  * How do blood levels of the test medicine compare when it is given in different forms?
  * Does the test medicine cause any important side effects?
  * Does food affect blood levels of the test medicine?

  This two-part study will take place at one non-NHS site in Nottingham.

  We plan to enrol up to 108 healthy men and women aged 18-55 years. In Part 1 up to 60 volunteers will be split evenly into up to five groups and in Part 2 up to 48 volunteers will be split evenly into up to four groups.

  In both parts, each group will be given a different form of the test medicine, and the results from Part 1 will determine which of the forms to be given in Part 2.

  Each volunteer will receive a single dose of one form of test medicine, as a tablet by mouth, with food in Part 1 and without food in Part 2. They’ll stay in the clinic for up to 7 nights on up to 1 occasion, attend up to 7 outpatient visits, and take up to 11 weeks to finish the study.

  We’ll collect blood and urine samples to:
  * do safety tests
  * measure the amount of test medicine

• REC name

  London - Brent Research Ethics Committee

• REC reference

  23/LO/0876

• Date of REC Opinion

  27 Nov 2023

• REC opinion

  Further Information Favourable Opinion