A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis



Status:Recruiting
Conditions:Neurology, Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:May 31, 2016
End Date:October 30, 2019
Contact:Reference Study ID Number: GN29823 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Single- and Multiple-Ascending-Dose Study to Determine Initial Safety, Tolerability, and Pharmacokinetics of GDC-0134 in Patients With Amyotrophic Lateral Sclerosis

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.


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
We found this trial at
11
sites
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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201 Dowman Drive
Atlanta, Georgia 30322
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Houston, Texas 77030
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Jacksonville, Florida 32224
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Knoxville, Tennessee 37920
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3801 Rue Université
Montreal, Quebec H3A 2B4
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100 West Gore Street
Orlando, Florida 32806
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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2324 Sacramento Street
San Francisco, California 94115
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San Francisco, CA
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