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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
Matching placebo in capsules administered as a single oral dose.
375 mg CK-2017357 in capsules administered as a single oral dose.
500 mg CK-2017357 in capsules administered as a single oral dose.
Tatum Ridge Internal Medicine
Phoenix, Arizona, United States
Apex Research Institute
Santa Ana, California, United States
Stanford Hospital and Clinics
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Stanford, California, United States
Denver Health Medical Center
Denver, Colorado, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
DMI Research, Inc
Pinellas Park, Florida, United States
Maine Research Associates
Auburn, Maine, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
...and 4 more locations
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