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

PHASE1CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

March 16, 2020

Study Completion Date

March 16, 2020

Conditions
Amyotrophic Lateral Sclerosis
Interventions
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

Trial Locations (10)

21205

Johns Hopkins University School of Medicine, Baltimore

27612

Wake Research Associates, Raleigh

30322

The Emory ALS Clinic, Atlanta

32224

Mayo Clinic Hospital - Florida, Jacksonville

33136

University of Miami Miller School of Medicine, Miami

37920

New Orleans Center for Clinical Research, Knoxville

94115

Forbes Norris Mda/als Ctr; Research Center, San Francisco

02114

Massachusetts General Hospital, Boston

H3A 2B4

MUCH - Montreal Neurological Institute & Hospital, Montreal

3508 GA

UMC Utrecht, Utrecht

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY

NCT02655614 - A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis | Biotech Hunter | Biotech Hunter