NCT01378676

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

A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In Part A, approximately 24 patients will be randomized to one of four different treatment groups. After a 7-day washout of riluzole, patients in each treatment group will receive daily oral doses of placebo, 125 mg, 250 mg, or 375 mg of CK-2017357 for 14 days. Patients will take daily doses of CK-2017357 or placebo (Day 1 through Day 14) and will return to the study site on Day 2, Day 8 and Day 15. All patients will return for a follow-up visit 7 days (± 2 days) after their last dose. In Part B, approximately additional 24 patients will be randomized to one of four different treatment groups as in Part A. Patients in Part B will be required to decrease their riluzole dose to 50 mg once a day (QD) for 7 days prior to randomization. After this 7 day period, patients will take riluzole at 50 mg QD concurrently with their morning dose of blinded study drug.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-06-22
• Last updated: 2019-05-07

Locations

9 sites across 1 country: United States