SAD, Food Effect and MAD study of GDC-0334 (QCL117876)
Research type
Research Study
Full title
A Phase I, Randomised, Double-Blind, Placebo-Controlled, 3-Part, Study Designed to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Multiple Ascending Doses of GDC-0334 and the Effect of Food on the Pharmacokinetics of GDC-0334 in Healthy Adult Subjects
IRAS ID
234252
Contact name
Doris Hsu
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2017-003498-33
Duration of Study in the UK
0 years, 7 months, 27 days
Research summary
The Sponsor is developing the study drug, GDC-0334, for the potential treatment of asthma.
The study will try to identify the safety, tolerability, pharmacokinetics (how well the study drug is taken up by the body), the effect of food on how well the study drug is taken up by the body and exploratory pharmacodynamics (the effects of the study drug on the body) of single and multiple doses of GDC-0334 given by mouth in healthy subjects.
The study will consist of 3 parts involving up to 106 healthy male and female subjects. In Part 1, up to 48 subjects will be enrolled into 1 of 6 regimens (optional regimen F) of 8 subjects, and will receive a single dose of GDC-0334 or placebo. The starting dose is 25 mg and safety, tolerability and pharmacokinetic data will be reviewed after each regimen to decide the dose that will be used for the next regimen.
Part 2 of the study consists of 3 regimens and will look at the effect of a high fat and low fat meal on the pharmacokinetics of a single dose of GDC-0334 given by mouth to 16 healthy subjects. The dose that will be used in Part 2 will be decided based on safety, tolerability and pharmacokinetic data from Part 1.
Part 3 of the study will look at the safety, tolerability and pharmacokinetics of multiple ascending doses of GDC-0334. 30 subjects will be assigned to 1 of 3 regimens, J, K, and L. 12 subject will be assigned to regimen M. subjects in regimens J, K, and L will receive a multiple dose of GDC-0334 or placebo once daily for up to 14 days and regimen M will receive multiple doses of GDC-0334 or matching placebo for 28 days.
REC name
HSC REC A
REC reference
17/NI/0205
Date of REC Opinion
13 Nov 2017
REC opinion
Further Information Favourable Opinion