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NCT02655614 · ClinicalTrials.gov registry record · Phase 1
A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT02655614 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 54 participants.
The verdict
NCT02655614, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
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.
Interventions
- DRUG Placebo
- DRUG Midazolam
- DRUG Caffeine
- DRUG Rabeprazole
- DRUG GDC-0134
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2016-05-31 |
| Est. Completion | 2020-03-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02655614
The ClinicalTrials.gov registry entry for NCT02655614 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02655614 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02655614 about?
NCT02655614 is a clinical study titled "A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis". 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 Mu...
What is the current status of trial NCT02655614?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2016-05-31. Estimated completion is 2020-03-16.
What interventions are being tested in trial NCT02655614?
The interventions under investigation include: Placebo (DRUG), Midazolam (DRUG), Caffeine (DRUG), Rabeprazole (DRUG), GDC-0134 (DRUG).
Who is sponsoring clinical trial NCT02655614?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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