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

Trial Profile

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

Recruiting
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
  • Most Recent Events

    • 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.
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