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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02655614
First received: January 7, 2016
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
The purpose of this study is to evaluate the safety and pharmacokinetics of GDC-0134 in patients with Amyotrophic Lateral Sclerosis (ALS).

Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Drug: GDC-0134
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: Up to 10 months ]
  • Number of participants with clinically significant laboratory abnormalities [ Time Frame: Up to 10 months ]
  • Number of participants with clinically significant vital signs abnormalities [ Time Frame: Up to 10 months ]
  • Number of participants with clinically significant electrocardiogram (ECG) abnormalities [ Time Frame: Up to 10 months ]
  • Number of participants with clinically significant abnormalities in physical examination findings [ Time Frame: Up to 10 months ]

Secondary Outcome Measures:
  • Maximum plasma concentration (Cmax) of GDC-0134 [ Time Frame: Up to 8 days ]
  • Time to maximum plasma concentration (tmax) of GDC-0134 [ Time Frame: Up to 8 days ]
  • Area under the concentration-time curve (AUC) of GDC-0134 [ Time Frame: Up to 8 days ]
  • Apparent clearance (CL/F) of GDC-0134 [ Time Frame: Up to 8 days ]
  • Apparent terminal volume of distribution (Vz/F) of GDC-0134 [ Time Frame: Up to 8 days ]
  • Apparent terminal half-life (t1/2) of GDC-0134 [ Time Frame: Up to 8 days ]

Estimated Enrollment: 39
Study Start Date: May 2016
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GDC-0134
Participants in multiple cohorts and treatment periods will receive single doses of GDC-0134 under fed/fasting conditions.
Drug: GDC-0134
GDC-0134 at various doses, depending on the cohort and treatment period.
Experimental: Placebo
Participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions.\n
Drug: Placebo
Placebo at various doses, depending on the cohort and treatment period.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02655614

Contacts
Contact: Reference Study ID Number: GN29823 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
United States, California
Recruiting
San Francisco, California, United States, 94115
United States, Florida
Recruiting
Jacksonville, Florida, United States, 32224
Recruiting
Miami, Florida, United States, 33136
Not yet recruiting
Orlando, Florida, United States, 32806
United States, Georgia
Recruiting
Atlanta, Georgia, United States
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02114
United States, Tennessee
Not yet recruiting
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02655614     History of Changes
Other Study ID Numbers: GN29823
Study First Received: January 7, 2016
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on March 24, 2017