The primary objective of the study is to evaluate dose proportionality and pharmacokinetics for three different dose levels of eliglustat after single and repeated administration.
Duration of the study for each subject will be between 42 to 79 days, including a screening period up to 28 days, 3 treatment periods of 7 days each period, a washup period of 7-10 days, and an end-of-study visit 8+/-2 days after the last administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
Pharmaceutical form:Capsule-Route of administration:Oral
M.D.Covance Clinical Research Unit 1341 W
Dallas, Texas, United States
Pharmacokinetic (PK) parameter: Cmax
Eliglustat after single and repeated doses: Maximum plasma concentration observed (Cmax)
Time frame: Multiple timepoints up to Day 35
Pharmacokinetic (PK) parameter: tmax
Eliglustat after single and repeated doses: Time to reach Cmax
Time frame: Multiple timepoints up to Day 35
Pharmacokinetic (PK) parameter: AUC0-T
Eliglustat after single and repeated doses: Area under the plasma concentration versus time curve calculated using the trapezoidal method (AUC0-T)
Time frame: Multiple timepoints up to Day 35
Pharmacokinetic (PK) parameter: AUC
Eliglustat after single and repeated doses: Area under the plasma concentration versus time curve (AUC)
Time frame: Multiple timepoints up to Day 35
Pharmacokinetic (PK) parameter: AUClast
Eliglustat after single and repeated doses: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
Time frame: Multiple timepoints up to Day 35
Pharmacokinetic (PK) parameter: tlast
Eliglustat after single and repeated doses: Time corresponding to the last concentration above the limit of quantification, Clast
Time frame: Multiple timepoints up to Day 35
Pharmacokinetic (PK) parameter: CL/F
Eliglustat after single and repeated doses: Eliglustat after repeated dose: CL/F
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Time frame: Multiple timepoints up to Day 35
Pharmacokinetic (PK) parameter: t1/2z
Eliglustat after single and repeated doses: Terminal half-life associated with the terminal slope (λz)
Time frame: Multiple timepoints up to Day 35
Pharmacokinetic (PK) parameter: Ctrough
Eliglustat after single and repeated doses: Plasma concentration observed just before treatment administration during repeated dosing
Time frame: Multiple timepoints up to Day 35
Number of participants with treatment emergent adverse events, serious adverse events, and adverse event of special interest
Safety was assessed using clinical laboratory evaluations, ECG parameters, and adverse events spontaneously reported by the subject or observed by the Investigator
Time frame: Up to Day 42