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:

The purpose of this study is to evaluate the safety and pharmacokinetics of GDC-0134 in patients with Amyotrophic Lateral Sclerosis (ALS).

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:

48

Estimated Study Start Date:

05/31/2016

Estimated Study Completion Date:

09/30/2017

Posting Last Modified Date:

05/17/2017

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):

    60

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    Inclusion Criteria:
    -Male or females 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 60 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 screening and without current liver enzyme or liver function abnormalities
    -Positive for hepatitis C antibody, hepatitis B surface antigen, or HIV antibody
    -Clinically significant thrombocytopenia
    -Currently taking nutritional/herbal supplements, except for over-the-counter vitamins that are within Recommended Dietary Allowance (RDA)

  • Site Contact Information

    Compass Research
    Orlando, Florida 32806
    United States

    Emory University
    Atlanta, Georgia 30322
    United States

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

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

    Mass General Hospital
    Boston, Massachusetts 02114
    United States

    Mayo Clinic Hospital - Florida
    Jacksonville, Florida 32224
    United States

    New Orleans Center for Clinical Research
    Knoxville, Tennessee 37920
    United States

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

    Wake Research Associates
    Raleigh, North Carolina 27612
    United States