A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis
NCT ID: NCT02655614
Last Updated: 2020-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
2016-05-31
2020-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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SAD Stage: GDC-0134
Participants in multiple cohorts and treatment periods will receive single doses of GDC-0134 oral capsules under fed/fasting conditions. To study the effect of proton pump inhibitor (PPI) medication rabeprazole on PK properties of GDC-0134, few participants may receive rabeprazole 20 milligrams (mg).
GDC-0134
GDC-0134 capsule will be administered orally at various doses, depending on the cohort and treatment period.
Rabeprazole
Rabeprazole 20 mg twice daily orally
SAD Stage: Placebo
Participants in multiple cohorts and treatment periods will receive placebo matching to GDC-0134 under fed/fasting conditions. Few participants may receive rabeprazole 20 mg.
Placebo
Placebo matching to GDC-0134
Rabeprazole
Rabeprazole 20 mg twice daily orally
MAD Stage: GDC-0134
Participants will receive multiple doses of GDC-0134 for 28 days. To study the interactions between GDC-0134 and other drugs, some participants may receive single doses of midazolam and caffeine at various time points.
GDC-0134
GDC-0134 capsule will be administered orally at various doses, depending on the cohort and treatment period.
Midazolam
2mg of liquid formulation of midazolam orally
Caffeine
100 mg tablet or solution of caffeine orally
MAD Stage: Placebo
Participants will receive placebo matching to GDC-0134 for 28 days. To study the interactions between GDC-0134 and other drugs, some participants may receive single doses of midazolam and caffeine at various time points.
Placebo
Placebo matching to GDC-0134
Midazolam
2mg of liquid formulation of midazolam orally
Caffeine
100 mg tablet or solution of caffeine orally
Open-Label Safety Expansion (OSE)
Participants will receive GDC-0134 at a dose determined by the corresponding MAD cohort.
GDC-0134
GDC-0134 capsule will be administered orally at various doses, depending on the cohort and treatment period.
Interventions
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GDC-0134
GDC-0134 capsule will be administered orally at various doses, depending on the cohort and treatment period.
Placebo
Placebo matching to GDC-0134
Rabeprazole
Rabeprazole 20 mg twice daily orally
Midazolam
2mg of liquid formulation of midazolam orally
Caffeine
100 mg tablet or solution of caffeine orally
Eligibility Criteria
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Inclusion 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 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Forbes Norris Mda/als Ctr; Research Center
San Francisco, California, United States
Mayo Clinic Hospital - Florida
Jacksonville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
The Emory ALS Clinic
Atlanta, Georgia, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Wake Research Associates
Raleigh, North Carolina, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
MUCH - Montreal Neurological Institute & Hospital
Montreal, Quebec, Canada
UMC Utrecht
Utrecht, , Netherlands
Countries
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Other Identifiers
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2017-002931-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GN29823
Identifier Type: -
Identifier Source: org_study_id
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