Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CK-2017357 · 5 trials · 3 indications
The ALSFRS-R is used to measure the progression and severity of disease; it consists of 12 questions, assessing a patient's capability and independence in functional activities relevant to ALS, categorized in 4 domains: gross motor tasks, fine motor tasks, bulbar functions, and respiratory function. Each question is scored from 0 (indicating incapable or dependent) to 4 (normal). The total score ranges from 0 to 48, with higher scores reflecting more normal function and lower scores reflecting more impaired function.
Safety and tolerability of CK-2017357 after multiple oral doses to steady state in patients with ALS
Heel raises will be monitored by an electrogoniometer placed on the index leg and performed once every other second until onset of claudication pain or fatigue as determined by electrogoniometry
Heel raises will be monitored by an electrogoniometer placed on the index leg and performed once every other second until limited by intolerable claudication pain or fatigue as determined by electrogoniometry
Patient's self-paced walking distance over 6 minutes
An instrument for evaluating the functional status of patients with ALS. Minimum score is 0 and maximum score is 40. The higher the score the more function is retained.
Measured using the DynEx Electronic Hand Dynamometer. Patients asked to squeeze the device with the maximum possible force to establish the maximum voluntary contraction.
Handgrip fatigue is measured using the DynEx Electronic Hand Dynamometer. Patient is asked to squeeze the device until they can no longer stay above 60% of target or 120 seconds.
Patient is asked to hold one arm outstretched in front of them at a 90 degree angle. The time the arm falls below 90 degrees for \> 2 seconds will be recorded, up to a total evaluation time of 2 minutes. This is then repeated with the other arm.
SVC is measured using the Puritan Bennett Renaissance II Spirometry System and accessories.
MVV is the volume of air that can be exhaled during 12 seconds of rapid deep breathing. The actual volume is extrapolated to one minute. the Puritan Bennett Renaissance II Spirometry System and accessories is used for this measurement.
SNIP is measured at Functional Residual Capacity, the bottom of the tidal breathing cycle, through one plugged nostril while the other remains open using the Micro Medical MicroRPM Respiratory Pressure Meter
MVC is measured using the MicroFET 2 HHD.
Sub-Maximum Grip Strength Fatigability is measured using the DynEx Electronic Hand. Dynamometer
| Arm | Type | Description |
|---|---|---|
| CK-2017357 | EXPERIMENTAL | 125 mg tablets |
| Placebo | PLACEBO_COMPARATOR | Placebo tablets |
| Dose Titration of CK-2017357 (Group 1) | EXPERIMENTAL | Dose titration of active drug as add-on therapy to riluzole |
| Matching Placebo (Group 2) | PLACEBO_COMPARATOR | Placebo as add-on therapy to riluzole |
| Matching Placebo | PLACEBO_COMPARATOR | - |
| Active Drug Low Dose (CK-2017357 125 mg) | EXPERIMENTAL | - |
| Active Drug Mid Dose (CK-2017357 250 mg) | EXPERIMENTAL | - |
| Active Drug High Dose (CK-2017357 375 mg) | EXPERIMENTAL | - |
| Treatment Sequence 1 | EXPERIMENTAL | Dosing Period 1 - Placebo; Dosing Period 2 - 375 mg CK-2017357; Dosing Period 3 - 500 mg CK-2017357 |
| Treatment Sequence 2 | EXPERIMENTAL | Dosing Period 1 - Placebo; Dosing Period 2 - 500 mg CK-2017357; Dosing Period 3 - 375 mg CK-2017357 |
| Treatment Sequence 3 | EXPERIMENTAL | Dosing Period 1 - 375 mg CK-2017357; Dosing Period 2 - Placebo; Dosing Period 3 - 500 mg CK-2017357 |
| Treatment Sequence 4 | EXPERIMENTAL | Dosing Period 1 - 375 mg CK-2017357; Dosing Period 2 - 500 mg CK-2017357; Dosing Period 3 - Placebo |
| Treatment Sequence 5 | EXPERIMENTAL | Dosing Period 1 - 500 mg CK-2017357; Dosing Period 2 - Placebo; Dosing Period 3 - 375 mg CK-2017357 |
| Treatment Sequence 6 | EXPERIMENTAL | Dosing Period 1 - 500 mg CK-2017357; Dosing Period 2 - 375 mg CK-2017357; Dosing Period 3 - Placebo |
| Name | Type | Description |
|---|---|---|
| CK-2017357 | DRUG | CK-2017357 125 mg tablets twice daily |
| Placebo tablets | OTHER | Tablets |
| Riluzole | DRUG | Tablets |
| Placebo | DRUG | Matching placebo tablets BID for 21 days |
| Riluzole 50 MG | DRUG | - |
| Placebo (Part A) | DRUG | Placebo tablets once daily for 14 days (Part A) |
| CK-2017357 (Part A) | DRUG | One 125 mg CK-2017357 tablet once daily for 14 days (Part A) |
| Riluzole 50 MG (Part B) | DRUG | One 50 mg tablet once daily for 14 days (Part B) |
| Placebo (Part B) | DRUG | Placebo tablets once daily for 14 days (Part B) |
| CK-2017357 (Part B) | DRUG | One 125 mg tablet once daily for 14 days (Part B) |
| 375 mg CK-2017357 | DRUG | 375 mg CK-2017357 in capsules administered as a single oral dose. |
| 500 mg CK-2017357 | DRUG | 500 mg CK-2017357 in capsules administered as a single oral dose. |
| 250 mg CK-2017357 | DRUG | 250 mg CK-2017357 in capsules administered as a single oral dose. |
Inclusion Criteria: 1. Able to comprehend and willing to sign an Informed Consent Form (ICF) 2. Male or female 18 years of age or older 3. A diagnosis of familial or sporadic ALS (defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS a...
CK-2017357 is an investigational small molecule being studied for the treatment of amyotrophic lateral sclerosis (ALS) and intermittent claudication associated with peripheral artery disease. It has completed Phase 2 clinical trials for both conditions, but it is not approved and remains in clinical development.
CK-2017357 is being developed by Cytokinetics, Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker CYTK. The company has sponsored multiple clinical trials of the drug in the United States.
CK-2017357 is in Phase 2 clinical development. All four completed trials of the drug were Phase 2 studies, including trials in amyotrophic lateral sclerosis and intermittent claudication. The drug is investigational and has not received FDA approval.
CK-2017357 has completed four Phase 2 clinical trials. These include NCT01089010 and NCT01378676 in amyotrophic lateral sclerosis, NCT01131013 in intermittent claudication and peripheral artery disease, and NCT01486849, a dose titration study in ALS. All trials were completed in the United States.
Yes, CK-2017357 was studied in amyotrophic lateral sclerosis in three completed Phase 2 trials: NCT01089010, NCT01378676, and NCT01486849. These trials enrolled a total of 143 patients with ALS and were conducted in the United States.
Yes, CK-2017357 was studied in intermittent claudication in a completed Phase 2 trial, NCT01131013. This trial enrolled 61 patients with peripheral artery disease and symptomatic claudication, and was conducted in the United States.