A study to look at a new medicine called, “GDC-0134”, for treating patients with amyotrophic lateral sclerosis (ALS)

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

Neurodegenerative Disorder
Amyotrophic Lateral Sclerosis

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Basic Details

Gender

All

Age

≥ 18 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT02655614, GN29823, 2017-002931-41

This clinical trial was done to study a new medicine called, “GDC-0134”, for the treatment of patients with amyotrophic lateral sclerosis (ALS). This study was done to find out how safe was it for patients with ALS to be treated with a new study medicine. Forty-nine patients took part in this study at 10 study centers in 3 countries.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT02655614, GN29823, 2017-002931-41

Condition Amyotrophic Lateral Sclerosis

Official Title 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

Study Summary

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.

Eligibility Criteria

Gender

All

Age

≥ 18 Years

Healthy Volunteers

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

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study to look at a new medicine called, “GDC-0134”, for treating patients with amyotrophic lateral sclerosis (ALS)

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

GN29823_LPS_2021Jan_Dutch_Netherlands (PDF, 0.2 MB)

GN29823_LPS_2021Jan_English (PDF, 0.2 MB)

GN29823_LPS_2021Jan_French_Canada (PDF, 0.2 MB)

GN29823_LPS_2021Jan_Spanish_USA (PDF, 0.2 MB)

What is Clinical Research?

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A study to look at a new medicine called, “GDC-0134”, for treating patients with amyotrophic lateral sclerosis (ALS)

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com