Spots Global Cancer Trial Database for Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis
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Trial Identification
Brief Title: Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis
Official Title: A Phase II, Double-Blind, Randomized, Three-Way Crossover, Placebo-Controlled, Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis on Standard Therapy
Study ID: NCT01268280
Conditions
Study Description
Brief Summary: 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 generalized myasthenia gravis (MG).
Detailed Description: This study is a Phase II, double-blind, randomized, three-way crossover, placebo-controlled, PD study of CK-2017357 in patients with generalized MG on standard therapy. 36 to 78 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, 250 mg, and 500 mg of CK-2017357. All six treatment sequences will enroll 6 patients. A wash out period of at least 7 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 the standardized Quantitative Myasthenia Gravis (QMG) score, Manual Muscle Test, Myasthenia Gravis Composite Assessment (MGCA) and Forced Vital Capacity. The pharmacokinetic (PK) and pharmacodynamic (PD) relationship of CK-2017357 after two single doses will be assessed versus placebo.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCSF - Fresno, Fresno, California, United States
University of California - Irvine, Orange, California, United States
California Pacific Medical Center, San Francisco, California, United States
Stanford University, Stanford, California, United States
Hospital for Special Care, New Britain, Connecticut, United States
The University of Kansas Medical Center, Kansas City, Kansas, United States
Johns Hopkins, Baltimore, Maryland, United States
Neurocare Center for Research, Newton, Massachusetts, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Duke University, Durham, North Carolina, United States
Drexel University College of Medicine, Philadelphia, Pennsylvania, United States
West Penn Allegheny Health System, Pittsburgh, Pennsylvania, United States
Baylor College of Medicine, Houston, Texas, United States
University of Texas Health Science Center, San Antonio, Texas, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Contact Details
Name: Andrew Wolff, MD, FACC
Affiliation: Cytokinetics, Inc.
Role: STUDY_DIRECTOR
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