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
Phase of Trial: Phase I
Latest Information Update: 21 Jul 2018
At a glance
- Drugs GDC 0134 (Primary) ; Caffeine; Midazolam; Rabeprazole
- Indications Amyotrophic lateral sclerosis
- Focus Adverse reactions; First in man
- Sponsors Genentech
- 28 Mar 2018 Open-Label Safety Expansion (OSE) stage added into trial, time frame of primary endpoint changed from 36 months to 48 months and number of treatment arms changed from 4 to 5.
- 28 Mar 2018 Planned number of patients changed from 72 to 82.
- 28 Mar 2018 Planned End Date changed from 30 Sep 2018 to 29 Oct 2019.