This is a Phase I, open-label, single-dose, 1-period study to compare EDG-5506 concentrations measured from venous and capillary blood sampling in healthy adult subjects. EDG-5506 is an investigational product designed to selectively modulate a fast skeletal muscle motor protein called myosin that is part of the contraction machinery of the damage-prone muscle fibers.
Ten (10) healthy, adult male and female (of non-childbearing potential only) participants will be enrolled in the single-site study. Participants will receive a single oral dose of EDG-5506 on Day 1. Serial blood sampling will be collected pre-dose and up to 26 hours post-dose using venous blood sampling by venipuncture and capillary blood sampling by a capillary blood self-sampling device. On Day 3, participants will self-collect a capillary blood sample at home. The final on-site visit will be on Day 7 when a last blood sample will be collected using venous blood sampling by venipuncture and capillary blood sampling by a capillary blood self-sampling device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
single oral dose
Celerion, Inc.
Lincoln, Nebraska, United States
Difference in area under the concentration-time curve (AUC0-24, AUC0-26, AUC0-144 and AUC0-t) measurements for EDG-5506 in blood collected by capillary blood self-sampling versus venous blood sampling
Time frame: 7 days
Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506 in blood collected by capillary blood self-sampling versus venous blood sampling
Time frame: 7 days
Time of maximum concentration (Tmax) measurements for EDG-5506 in blood collected by capillary blood self-sampling versus venous blood sampling
Time frame: 7 days
Area under the concentration-time curve (AUC0-24, AUC0-26, AUC0-144 and AUC0-t) measurements for EDG-5506 in plasma.
Time frame: 7 days
Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506 in plasma.
Time frame: 7 days
Time of maximum concentration (Tmax) measurements for EDG-5506 in plasma.
Time frame: 7 days
Incidence of treatment-emergent adverse events
Time frame: 7 days
Incidence of abnormal clinical laboratory test results
Time frame: 7 days
Incidence of abnormal vital signs
Time frame: 7 days
Incidence of abnormal electrocardiograms (ECGs)
Time frame: 7 days
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