Relative Bioavailability of GDC-0134 (QCL117864)
Research type
Research Study
Full title
A Phase I Open-Label Study to Determine the Relative Bioavailability of GDC-0134 and to Investigate the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Subjects
IRAS ID
222524
Contact name
Jay Bordoloi
Contact email
Sponsor organisation
Genentech Inc
Eudract number
2017-000299-27
Duration of Study in the UK
0 years, 4 months, 8 days
Research summary
The Sponsor is developing the study drug, GDC-0134, for the potential treatment of Amyotrophic Lateral Sclerosis (ALS), also known in the UK as Motor Neurone Disease.
ALS is a rare, incurable disease that attacks the nerve cells (neurons) responsible for controlling voluntary muscle movement (muscle action we are able to control). When the nerve cells degenerate or die, they stop sending messages to the muscles, causing loss of control and strength. This not only affects movement in the arms and legs (walking and gripping), it can affect speech, and the ability to swallow and breathe. ALS affects approximately 3 in every 100,000 adults in the United States, most commonly people between the ages of 40 and 70 years . Most patients with ALS die within 3 to 5 years after they are diagnosed with the disease.
GDC-0134 is a new medicine that is intended to protect neurons from degeneration. This 4 period study in approximately 28 healthy females will look at how GDC-0134 is taken up by the body and how this is affected by taking with food and a proton pump inhibitor. A proton pump inhibitor reduces the amount of acid made by your stomach.
REC name
HSC REC A
REC reference
17/NI/0072
Date of REC Opinion
28 Apr 2017
REC opinion
Favourable Opinion