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March 27, 2014
07:36 EDTCYTKCytokinetics initiates multiple dose Phase I clinical trial of CK-2127107
Cytokinetics (CYTK) announced the initiation of an additional Phase I clinical trial of CK-2127107, a fast skeletal muscle troponin activator. The trial, called CY 5012, is a double-blind, randomized, placebo-controlled, parallel group study in which the primary objective is to assess the safety, tolerability, and pharmacokinetics of CK-2127107 following multiple ascending doses in healthy volunteers. The initiation of this clinical trial triggers a $2M milestone payment from Astellas Pharma (ALPMF) to Cytokinetics under the terms of the collaboration between the companies established in June 2013. In CY 5012, volunteers in each ascending dose cohort will be randomized to receive either CK-2127107 or placebo. CY 5012 will separately enroll cohorts of volunteers in two age groups, one between the ages of 18 and 55 and one between the ages of 65 and 85. Each cohort will be comprised of six male and six female participants. In each cohort, volunteers will receive CK-2127107 or placebo in accordance with 2:1 randomization. An initial cohort in each age group will receive 300 mg of CK-2127107 or placebo to be followed by a second cohort in each age group that will receive 1000 mg of CK-2127107 or placebo. Doses of CK-2127107 and placebo will be administered orally for 10 days. If these doses of CK-2127107 are well-tolerated, a final cohort of volunteers between the ages of 18 and 55 will receive CK-2127107 at either 1500 mg or 2000 mg, to be determined following a review of data from the prior dose cohorts or placebo. In each cohort, pharmacokinetic assessments will be performed following the first dose of CK-2127107 and throughout the study to day 10.
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