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A Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT01378676 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-05-07

No results posted yet for this study

Summary

The study will generate data on safety, tolerability and pharmacokinetics after multiple daily doses of CK-2017357 in patients with ALS. Patients will be randomized into one of four different treatment groups, receiving daily oral doses of either placebo, 125 mg, 250 mg, or 375 mg of CK-2017357 for 14 days.

Conditions

Interventions

DRUG

Placebo (Part A)

Placebo tablets once daily for 14 days (Part A)

DRUG

CK-2017357 (Part A)

One 125 mg CK-2017357 tablet once daily for 14 days (Part A)

DRUG

CK-2017357 (Part A)

Two 125 mg CK-2017357 tablets once daily for 14 days (Part A)

DRUG

CK-2017357 (Part A)

Three 125 mg CK-2017357 tablets once daily for 14 days (Part A)

DRUG

Riluzole 50 MG (Part B)

One 50 mg tablet once daily for 14 days (Part B)

DRUG

Placebo (Part B)

Placebo tablets once daily for 14 days (Part B)

DRUG

CK-2017357 (Part B)

One 125 mg tablet once daily for 14 days (Part B)

DRUG

CK-2017357 (Part B)

Two 125 mg tablets once daily for 14 days (Part B)

DRUG

CK-2017357 (Part B)

Three 125 mg tablets once daily for 14 days (Part B)

Sponsors & Collaborators

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • Jeremy Shefner, MD, PhD · State University of New York - Upstate Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01378676 on ClinicalTrials.gov