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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
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- Atlanta
- Baltimore
- Boston
- Jacksonville
- Knoxville
- Miami
- Montréal
- Raleigh
- San Francisco
- Utrecht
Trial Identifier:
NCT02655614 2017-002931-41 GN29823
Trial 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.
Genentech, Inc.
Sponsor
Phase 1
Phase
NCT02655614, GN29823, 2017-002931-41
Trial Identifier
All
Gender
≥ 18 Years
Age
No
Healthy Volunteers
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.
Trial 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.
Genentech, Inc.
Sponsor
Phase 1
Phase
NCT02655614, GN29823, 2017-002931-41
Trial Identifier
GDC-0134, Placebo, Rabeprazole, Midazolam, Caffeine
Treatments
Amyotrophic Lateral Sclerosis
Condition
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
Eligibility Criteria
All
Gender
≥ 18 Years
Age
No
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
For the latest version of this information please go to www.forpatients.roche.com