MedTrace Logo

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

NCT02655614 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-08-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2020-03-16
Completion
2020-03-16
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655614 on ClinicalTrials.gov