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

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 two components: a Single-Ascending-Dose (SAD) stage and a Multiple-Ascending-Dose (MAD) stage.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Active, currently recruiting

Phase:

Phase I

Study Chair(s)/Principal Investigator(s):

Hoffmann-La Roche

Clinicaltrials.gov ID (11 digit #):

NCT02655614

Neals Affiliated?

No

Coordinating Center Contact Information


Reference Study ID Number: GN29823 / .(JavaScript must be enabled to view this email address) / 888-662-6728
.(JavaScript must be enabled to view this email address) United States

Full Study Summary:

Study Sponsor:

Genentech, Inc.

Participant Duration:

Estimated Enrollment:

72

Estimated Study Start Date:

05/31/2016

Estimated Study Completion Date:

09/30/2018

Posting Last Modified Date:

11/15/2017

Date Study Added to alsconsortium.org:

01/26/2016
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Min Vital Capacity (% predicted normal):

    50

    Time since Symptom Onset:

    Time since Diagnosis:

    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

  • Site Contact Information

    Forbes Norris Mda/als Ctr; Research Center
    San Francisco, California 94115
    United States

    Compass Research
    Orlando, Florida 32806
    United States

    University of Miami Miller School of Medicine
    Miami, Florida 33136
    United States

    Mayo Clinic Hospital - Florida
    Jacksonville, Florida 32224
    United States

    Emory University
    Jane Bordeau / .(JavaScript must be enabled to view this email address) / 404-727-1679
    Atlanta, Georgia 30322
    United States

    Johns Hopkins University School of Medicine
    Baltimore, Maryland 21205
    United States

    Mass 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

    Methodist Neurological Institute
    Houston, Texas 77030
    United States

    Montreal Neurological Institute & Hospita
    Montreal, Quebec H3A 2B4
    Canada

    UMC Utrecht
    Utrecht, Netherlands 3508 GA
    Netherlands