GB29751 Single and Multiple ascending dose study

• Research type

  Research Study

• Full title

  GB29751 – A Phase I, Randomized, Blinded, Placebo Controlled, Ascending, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects

• IRAS ID

  174117

• Contact name

  Catherine Laing

• Contact email

  catherine.laing@covance.com

• Sponsor organisation

  Genentech Inc

• Duration of Study in the UK

  0 years, 4 months, 15 days

• Research summary

  The Study Drug (GDC-3280) is an investigational drug which is being developed by with an aim to help people with idiopathic pulmonary fibrosis (IPF), a disease of the lungs.

  This is the first time that the GDC-3280 is being given to humans. Study will be blinded (neither the Investigator nor the subject will be aware of treatment assignment) and placebo-controlled ( dummy medication for some subjects )

  There are two parts:

  Part A
  Approximately 56 subjects will be studied in 6 groups ( A1 to A6), with each of groups A1, A2, A3, A5 and A6 consisting of 8 subjects (6 GDC-3280, 2 placebo) and Group A4 consisting of up to 16 subjects (12 GDC-3280, 4 placebo).

  This will consist of up to four treatment periods. All subjects in Groups A1 through A6 will participate in Treatment Period (TP) 1, and will receive the fasted treatment regimen.

  Group A4 (and possibly Groups A5 and A6) will participate in TPs 2, 3 and 4.
  This has been designed to look at whether taking the tablets with food or Rabeprazole affects the amount of study drug that gets into the blood in healthy male and female subjects.

  Part B
  Approximately 24 subjects will be studied in 3 groups with each group consisting of 8 subjects (6 GDC-3280, 2 placebo).

  Each subject will participate in one treatment period only. For all subjects, once-daily dosing is planned; however, this may be increased up to three times-daily. Dosing will occur on Days 1 through 7 inclusive. The duration of dosing may be extended to 14 days.

• REC name

  North East - York Research Ethics Committee

• REC reference

  15/NE/0092

• Date of REC Opinion

  21 Apr 2015

• REC opinion

  Further Information Favourable Opinion