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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: Completed Phase 1 study, sponsored by Genentech.
NCT02655614 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02655614 record still lists
NCT02655614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02655614 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02655614's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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