A Phase 2 interventional study of Placebo and 375 mg CK-2017357 in Intermittent Claudication and Peripheral Artery Disease, sponsored by Cytokinetics. Completed at 14 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-05-14.
Sponsored by Cytokinetics · Phase 2, Interventional, and Treatment
The primary objective of this early-stage clinical study is to demonstrate an effect of single doses of CK-2017357 on measures of skeletal muscle function and fatigability in patients with peripheral artery disease and symptomatic claudication.
This study is a Phase II, double-blind, randomized, placebo-controlled, three-way crossover design of two single doses of CK-2017357 in patients with peripheral artery disease and symptomatic claudication. 36 to 72 patients will be randomized at approximately 15 study centers to one of six different treatment sequences. Each treatment sequence consists of three dosing periods in which patients receive single oral doses of placebo, 375 mg and 500 mg of CK-2017357. All six treatment sequences will enroll approximately the same number of patients. A wash out period of at least 6 days (to a maximum of 10 days) will be employed between the individual doses for each patient. This study is designed to assess the effects of CK-2017357 on measures of endurance/fatigue, work output, and walking capacity. The PK and PD relationship of CK-2017357 after two single doses will be assessed versus placebo, and the CK-2017357 concentration versus time data obtained in this study may be used to develop a population PK model to estimate intra- and inter-patient variability of PK parameters in patients with claudication.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 61 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Cytokinetics is the lead sponsor of 41 studies on the registry; 3 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
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For female patients only: Non-childbearing potential (e.g., documented post-menopausal ≥ 1 year, sterilized, status-post hysterectomy) For male patients only: Agreement either
Exclusion Criteria:
Dosing Period 1 - Placebo; Dosing Period 2 - 375 mg CK-2017357; Dosing Period 3 - 500 mg CK-2017357
Drug: Placebo · Drug: 375 mg CK-2017357 · Drug: 500 mg CK-2017357
Dosing Period 1 - Placebo; Dosing Period 2 - 500 mg CK-2017357; Dosing Period 3 - 375 mg CK-2017357
Drug: Placebo · Drug: 375 mg CK-2017357 · Drug: 500 mg CK-2017357
Dosing Period 1 - 375 mg CK-2017357; Dosing Period 2 - Placebo; Dosing Period 3 - 500 mg CK-2017357
Drug: Placebo · Drug: 375 mg CK-2017357 · Drug: 500 mg CK-2017357
Dosing Period 1 - 375 mg CK-2017357; Dosing Period 2 - 500 mg CK-2017357; Dosing Period 3 - Placebo
Drug: Placebo · Drug: 375 mg CK-2017357 · Drug: 500 mg CK-2017357
Dosing Period 1 - 500 mg CK-2017357; Dosing Period 2 - Placebo; Dosing Period 3 - 375 mg CK-2017357
Drug: Placebo · Drug: 375 mg CK-2017357 · Drug: 500 mg CK-2017357
Dosing Period 1 - 500 mg CK-2017357; Dosing Period 2 - 375 mg CK-2017357; Dosing Period 3 - Placebo
Drug: Placebo · Drug: 375 mg CK-2017357 · Drug: 500 mg CK-2017357
Matching placebo in capsules administered as a single oral dose.
375 mg CK-2017357 in capsules administered as a single oral dose.
Also known as: tirasemtiv
500 mg CK-2017357 in capsules administered as a single oral dose.
Also known as: tirasemtiv
Effect of single dose of CK-2017357 on number of contractions, time and work to onset of claudication during bilateral heel raises
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
Time frame: 1 day
Effect of single dose of CK-2017357 on number of contractions, time and work to intolerable claudication pain or maximal calf muscle fatigue
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
Time frame: 1 day
Effect of single dose of CK-2017357 on Six-Minute Walk Test
Patient's self-paced walking distance over 6 minutes
Time frame: 1 day
Characterize the relationship, if any, between the plasma concentrations of CK-2017357 and number of contractions, time and work to onset of claudication during bilateral heel raises
Bilateral heel raise assessments will be paired with PK concentrations obtained at or near the same time as the bilateral heel raises assessments and analyzed for concentration related effects
Time frame: 1 day
Characterize the relationship, if any, between the plasma concentrations of CK-2017357 and number of contractions, time and work to intolerable claudication pain or maximal calf muscle fatigue during bilateral heel raises
Bilateral heel raise assessments will be paired with PK concentrations obtained at or near the same time as the bilateral heel raises assessments and analyzed for concentration related effects
Time frame: 1 day
Characterize the relationship, if any, between the plasma concentrations of CK-2017357 and Six-Minute Walk Test
Six-Minute Walk Test will be paired with PK concentrations obtained at or near the same time Six Minute Walk Test and analyzed for concentration related effects
Time frame: 1 day
Number of patients with adverse events
Time frame: 4 weeks
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Cytokinetics