This study will evaluate the amount of drug that reaches the circulation when a subject takes the test (liquid) formulation compared to the reference (capsule) formulation. The study will also examine the effect of a high fat meal on the levels of drug in blood.
This is a phase 1, open-label, randomized, three-period, two-way crossover study in healthy subjects. The study will consist of a screening phase, a baseline phase, three treatment periods, and a follow-up phone call. Each period will be two days in duration (Day 1 through Day 2) for dosing and sample collection. There will be a minimum of four days washout between doses. Within no more than 21 days (Day -21) and no less than two days (Day -2) prior to the start of Period 1, subjects will undergo routine screening procedures including physical examination (PE), 12-lead electrocardiogram (ECG), vital signs, clinical laboratory safety tests (serum chemistry, hematology, and urinalysis), serology screen, and drug/alcohol screen. Eligible subjects will be admitted into the study center on Day -1 of Period 1 for baseline assessments. During each period, subjects will receive a single 25 mg oral dose of lenalidomide on Day 1 according to the assigned treatment sequence. Serial blood sampling for the determination of lenalidomide concentrations in plasma will be performed for 24 hours post dose, and safety will be evaluated. Subjects will be domiciled at the study center from Day 1 of Period 1 through Day 2 of Period 3, including the 4 day washout between each dose of IP. All subjects will be discharged from the study center on Day 2 of Period 3 following completion of required study procedures. A follow-up phone call will occur approximately four days (±2 days) after discharge from the study center. The study will be conducted in compliance with International Conference on Harmonisation (ICH) Good Clinical Practices (GCPs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
Covance-Daytona Beach
Daytona Beach, Florida, United States
Pharmacokinetics - AUCt
Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration
Time frame: approximately 11 days
Pharmacokinetics - AUC∞
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: approximately 11 days
Pharmacokinetics - Cmax
Maximum observed plasma concentration
Time frame: approximately 11 days
Pharmacokinetics - Tmax
Time to maximum plasma concentration
Time frame: approximately 11 days
Pharmacokinetics - T1/2
Terminal phase half-life in plasma
Time frame: approximately 11 days
Pharmacokinetics - CL/F
Apparent total clearance when dosed orally
Time frame: approximately 11 days
Pharmacokinetics - Vz/F
Apparent volume of distribution when dosed orally
Time frame: approximately 11 days
Adverse Events (AEs)
Number of participants with adverse events
Time frame: up to 5 weeks
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