A Phase 1 interventional study of CC-220 and CC-220 in Healthy Volunteers, sponsored by Celgene Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-13.
Sponsored by Celgene Corporation · Phase 1 and Interventional
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of CC-220 in healthy subjects and to evaluate the relative bioavailability of a formulated CC-220 capsule
This is a 3-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 4 cohorts, each of which consists of a different dose level and/or dosing duration, with 8 or 9 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC-220 and the remaining subjects will receive placebo depending on the randomization schedule. In 2 of the cohorts, study drug will be administered once daily for a total of 14 days. In the other 2 cohorts, study drug will be administered once daily for 28 days. In one of the 28-day dosing cohorts, 2 vaccinations (tetanus toxoid adsorbed and pneumococcal vaccinations) will also be administered on Day 14 of the 28-day dosing period to help characterize the effect of CC-220 on antibody responses. Part 2 is a randomized, double-blind, placebo-controlled, parallel-group study to explore the effects of an alternative dosing schedule on the pharmacodynamics of CC-220. During the course of Part 2, 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 2 cohorts, each of which consists of a different dose level, with 9 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC-220 and 3 subjects will receive placebo depending on the randomization schedule. The dosing frequency will be either once every 3 days for 14 days or once every 7 days for 28 days. Part 3 is a randomized, open-label, two-period, two-way crossover study to evaluate the relative bioavailability of one CC-220 formulated capsule, relative to two reference capsules, following a single oral dose of CC-220. During the course of Part 3, each subject will participate in a screening phase, a baseline phase, a treatment phase consisting of 2 periods, and a follow up visit. There will be one cohort consisting of a total of 12 subjects. In each study period, approximately 6 subjects will receive a single dose of CC-220 as one formulated capsule (test product) and approximately 6 subjects will receive a single dose of CC-220 as two reference capsules (reference product).
Celgene Corporation is the lead sponsor of 50 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Must understand and voluntarily sign a written informed consent document prior to any study-related procedures being performed.
For females: Female subjects must have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 months without menses before screening, with an estradiol level of \< 30 pg/mL and follicle-stimulating hormone level of > 40 IU/L at screening).
Exclusion Criteria:
History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders.
Drug: CC-220
Drug: CC-220
Drug: CC-220
Drug: CC-220
Drug: Placebo
Drug: CC-220
Drug: CC-220
Drug: CC-220
CC-220 0.3mg will be administered once daily for 14 days
CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination
CC-220 0.3mg will be administered once daily for 28 days
CC-220 1mg will be administered once daily for 7 days on 2 separate occasions, with a 7-day washout in between, for a total of 14 days of dosing
Placebo will be administered once daily for up to 28 days
CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses)
CC-220 1mg (once every 7 days for 28 days)
CC-220 1mg will be administered as a single dose in each of 2 study periods; once as a formulated capsule and once as two reference capsules
Adverse Events
Number of participants with adverse events
Time frame: Up to 7 months overall
Concentrations of CC-220 and its R-enantiomer in plasma
Blood samples will be collected at pre-specified times to determine levels of CC-220 and its R-enantiomer in plasma
Time frame: Up to 30 days per cohort
Pharmacodynamic Assessmens
Blood samples will be collected at pre-specified times for pharmacodynamic assessments
Time frame: Up to 42 days per cohort
Pharmacokinetics - Cmax
Maximum observed plasma concentration
Time frame: Up to 30 days
Pharmacokinetics - tmax
Time to Cmax
Time frame: Up to 30 days
Pharmacokinetics - AUCinf
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: Up to 30 days
Pharmacokinetics - AUCt
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Time frame: Up to 30 days
Pharmacokinetics - AUCtau
Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval
Time frame: Up to 30 days
Pharmacokinetics - t1/2,z
Terminal-phase elimination half-life
Time frame: Up to 30 days
Pharmacokinetics - CL/F
Apparent total plasma clearance when dosed orally
Time frame: Up to 30 days
Pharmacokinetics - Vz/F
Apparent total volume of distribution when dosed orally, based on the terminal phase
Time frame: Up to 30 days
Accumulation Ratio (RA)
Accumulation Ratio for Cmax and AUCtau
Time frame: Up to 30 days
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Celgene Corporation