drugset / Trial / NCT02655614
A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis
RandomizedSequentialDouble-blindTreatment
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.
Timeline
- Start
- 2016-05-31
- Primary completion
- 2020-03-16
- Completion
- 2020-03-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | 100 mg | Oral |
| Subject | GDC-0134 | Small molecule | — | Oral |
| Subject | Midazolam | Small molecule | 2 mg | Oral |
| Subject | Rabeprazole | Small molecule | 20 mg | Oral |