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

Completed · Phase 1 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT02655614

Run by

Genentech, Inc.

People needed

54

Starts

2016-05-31

Expected to finish

2020-03-16

Last updated by the study team

2020-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Forbes Norris Mda/als Ctr; Research Center — San Francisco, California, United States
• Mayo Clinic Hospital - Florida — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• The Emory ALS Clinic — Atlanta, Georgia, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• New Orleans Center for Clinical Research — Knoxville, Tennessee, United States
• MUCH - Montreal Neurological Institute & Hospital — Montreal, Quebec, Canada
• UMC Utrecht — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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