NCT01131013

A Study of CK-2017357 in Patients With Peripheral Artery Disease and Symptomatic Claudication

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Three-Way Crossover, Pharmacokinetic and Pharmacodynamic Study of CK-2017357 in Patients With Claudication

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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 peripheral artery disease and symptomatic claudication.

Detailed description

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.

Conditions

• Intermittent Claudication
• Peripheral Artery Disease

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo in capsules administered as a single oral dose.
DRUG	375 mg CK-2017357	375 mg CK-2017357 in capsules administered as a single oral dose.
DRUG	500 mg CK-2017357	500 mg CK-2017357 in capsules administered as a single oral dose.

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-05-26
• Last updated: 2019-05-14

Locations

14 sites across 1 country: United States