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
- Amyotrophic Lateral Sclerosis
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