NCT02655614

A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	GDC-0134	GDC-0134 capsule will be administered orally at various doses, depending on the cohort and treatment period.
DRUG	Placebo	Placebo matching to GDC-0134
DRUG	Rabeprazole	Rabeprazole 20 mg twice daily orally
DRUG	Midazolam	2mg of liquid formulation of midazolam orally
DRUG	Caffeine	100 mg tablet or solution of caffeine orally

Timeline

• Start date: 2016-05-31
• Primary completion: 2020-03-16
• Completion: 2020-03-16
• First posted: 2016-01-14
• Last updated: 2020-08-06

Locations

10 sites across 3 countries: United States, Canada, Netherlands

Regulatory

• FDA-regulated drug study