Study Purpose:
This first-in-human, double-blind, placebo-controlled Phase I study will be conducted in participants with amyotrophic lateral sclerosis (ALS) to explore safety, tolerability, and pharmacokinetic (PK) properties of GDC-0134. It will include three components: a Single-Ascending-Dose (SAD) stage, a Multiple-Ascending-Dose (MAD) stage, and an Open-Label Safety Expansion (OSE) stage.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
GDC-0134, Placebo, Rabeprazole, Midazolam, Caffeine
Placebo:
Yes
Phase:
Phase 1
Study Chair(s)/Principal Investigator(s):
Clinical Trials, Hoffmann-La Roche
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
United States
Study Sponsor:
Genentech, Inc.
Estimated Enrollment:
54
Estimated Study Start Date:
05 / 31 / 2016
Estimated Study Completion Date:
03 / 16 / 2020
Posting Last Modified Date:
08 / 06 / 2020
Date Study Added to neals.org:
01 / 14 / 2016
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
Inclusion Criteria:- Male or female participants with a diagnosis of possible, laboratory-supported probable, probable, or definite ALS according to modified El Escorial criteria
- Upright forced vital capacity of at least 50 percent (%)
- Ability to fast from food for 8 hours prior to dosing and 2 hours after dosing
Exclusion Criteria:
- Currently taking riluzole unless on a stable dose for the 3 months prior to Day -1 and without current liver enzyme or liver function abnormalities
- Currently taking edaravone unless after completion of at least the second 14-day drug-treatment period, as long as Day 1 occurs during a drug-free period at least 24 hours after the last edaravone dose and at least 5 days prior to the first dose of the next cycle
- Positive for hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus (HIV) antibody
- Clinically significant thrombocytopenia
- Currently taking nutritional/herbal supplements, except for over-the-counter vitamins that are within Recommended Dietary Allowance (RDA), unless discontinued at least 7 days prior to Day -1, except upon approval of both the investigator and Sponsor
- For participants participating in a designated drug-drug interaction (DDI) cohort in the MAD stage of the study, who require midazolam/caffeine administration: known allergy, religious prohibition, or other condition limiting midazolam or caffeine administration
Forbes Norris Mda/als Ctr; Research Center
San Francisco, California
94115
United States
Mayo Clinic Hospital - Florida
Jacksonville, Florida
32224
United States
University of Miami Miller School of Medicine
Miami, Florida
33136
United States
The Emory ALS Clinic
Atlanta, Georgia
30322
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland
21205
United States
Massachusetts General Hospital
Boston, Massachusetts
02114
United States
Wake Research Associates
Raleigh, North Carolina
27612
United States
New Orleans Center for Clinical Research
Knoxville, Tennessee
37920
United States
MUCH - Montreal Neurological Institute & Hospital
Montreal, Quebec
H3A 2B4
Canada
UMC Utrecht
Utrecht 3508 GA
Netherlands