To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of CC-220 and to explore the effect of food on the bioavailability of CC-220 in healthy subjects
This is a 2-part study to be conducted at a single study center. Part 1 is a randomized, double-blind, placebo-controlled, ascending-dose study. During the course of Part 1, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow-up visit. There will be a total of 7 cohorts, each of which consists of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC-220 and 2 subjects will receive placebo depending on the randomization schedule. A single dose will be administered to each subject. This study design allows safety and tolerability data to be gathered in a stepwise fashion. Administration of study drug at the next higher dose level will not begin until the safety and tolerability of the preceding dose have been evaluated and deemed acceptable by the investigator and sponsor's medical monitor. Part 2 is an open-label, randomized, 2-period, 2-way crossover study. During the course of Part 2, each subject will participate in a screening phase, a baseline phase in each study period, a treatment phase in each study period and a follow-up visit. A total of 10 subjects will receive a single dose of 1 mg CC-220 in each of 2 study periods, once without food and once with food, depending on the treatment sequence to which they are randomized. The CC-220 dose in each study period will be separated by a washout of 11 to 14 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
65
A single dose of CC-220 0.03 mg will be administered orally once a day.
A single dose of CC-220 0.1 mg will be administered orally once a day.
A single dose of CC-220 0.3 mg will be administered orally once a day.
Covance Clinical Research Unit
Madison, Wisconsin, United States
Adverse Events
Number of study participants with Adverse Events
Time frame: Up to 5 months overall
Concentrations of CC-220 and its R-enantiomer in plasma (Part 2 only)
Blood samples will be collected at pre-specified times to determine levels of CC-220 free base and its R-enantiomer in plasma
Time frame: Up to 3 days in each period
Concentrations of CC-220 and its R-enantiomer in plasma (Part 1 only)
Blood samples will be collected at pre-specified times to determine levels of CC-220 free base and its R-enantiomer in plasma
Time frame: Up to 3 days
PK-Cmax
Cmax: Maximum observed plasma concentration
Time frame: Up to 3 days
PK-Tmax
Time to Maximum Plasma Concentration
Time frame: Up to 3 days
PK-AUC 0-∞
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: Up to 3 days
PK-AUC 0-t
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Time frame: Up to 3 days
PK-t1/2,z
Terminal-phase elimination half-life
Time frame: Up to 3 days
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A single dose of CC-220 1 mg will be administered orally once a day.
A single dose of CC-220 2 mg will be administered orally once a day.
A single dose of placebo will be administered orally once a day.
CC-220 4 mg will be administered orally once a day
CC-220 6 mg will be administered orally once a day
CC-220 1 mg will be administered orally once a day in each of 2 study periods - once with food and once without food
PK-CL/F
Apparent total plasma clearance when dosed orally
Time frame: Up to 3 days
PK-Vz/F
Apparent total volume of distribution when dosed orally, based on the terminal phase
Time frame: Up to 3 days
PK-Ae48
Cumulative amount of drug excreted unchanged in urine through 48 hours postdose
Time frame: Up to 3 days
PK-fe48
Cumulative percentage of the administered dose excreted unchanged in urine through 48 hours postdose
Time frame: Up to 3 days
PK-CLr
Renal clearance
Time frame: Up to 3 days