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The study is being conducted to compare how long 2 oral formulations (a reference and a test formulation) of CC-122 stays in the body, and whether taking the test formulations with a high-fat meal affects the absorption of that formulation. There will be 3 dosing periods in the study, one for each formulation and one for the test formulation + meal. The subjects will be asked to fast for at least 10 hours before taking the capsule formulations. During one of the periods, the subject will be asked to eat a high-fat meal 30 minutes before being given the capsule to swallow. Subjects will be randomly (by chance) assigned to a treatment sequence which will determine the order in which the subject will receive the reference formulation, the test formulation, and the test formulation + high-fat meal. Blood samples will be taken at intervals during the study to assess the amount of drug at those time points. Blood samples will also be collected at certain time points to determine the levels of special proteins that may help explain how CC-122 work.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 mg CC-122 reference capsule formulation | Experimental | 3 mg CC-122 reference capsule given by mouth with 240 mL of room temp tap water |
|
| 3 mg CC-122 test capsule formulation | Experimental | 3 mg CC-122 test capsule give by mouth with 240 mL of room temp tap water |
|
| 3 mg CC-122 test capsule + high fat meal | Experimental | 3 mg CC-122 test capsule given by mouth with 240 mL of room temp tap water approximately 5 minutes after eating a high-fat meal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-122 | Drug | CC-122 |
| |
| CC-122 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - AUC | Area under the plasma concentration-time curve | up to about 21 days after first dosing |
| Pharmacokinetics - Cmax | Maximum observed concentration in plasma | up to about 21 days after first dosing |
| Pharmacokinetics - Tmax | Time to maximum concentration | up to about 21 days after first dosing |
| Pharmacokinetics - T1/2 | Terminal half-life (T1/2) | up to about 21 days after first dosing |
| Pharmacokinetics - CL/F | Apparent total body clearance | up to about 21 days after first dosing |
| Pharmacokinetics - Vz/f | Apparent volume of distribution | up to about 21 days after first dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Safety monitoring will be done by regular adverse event assessment, concomitant medication, clinical laboratory tests, physical exams, ECGs, and vital signs. | approximately 7-8 weeks |
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Inclusion Criteria:
Subjects must satisfy ALL of the following criteria to be enrolled in the study:
Must understand and voluntarily sign a written Informed Consent Document prior to any study-related assessments/procedures being performed and be able to adhere to restrictions and examination schedules.
Must be able to communicate with the Investigator and to understand and adhere to the study visit schedule and other protocol requirements.
Must be a male of any race, aged 18 years of age to 65 years of age (inclusive) at the time of signing the Informed Consent Document.
Has a body mass index (BMI = weight [kilograms (kg)]/(height [m2])) between 18 and 33 kg/m2 (inclusive).
Must be healthy as determined by the Investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiograms.
Must practice true abstinence* or agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or a female of child-bearing potential while participating in this study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
Exclusion Criteria:
The presence of ANY of the following will exclude a subject from enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| Edward O'Mara, MD | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Development Services | Daytona Beach | Florida | 32117 | United States |
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| ID | Term |
|---|---|
| C000602306 | 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione |
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| Drug |
CC-122 |
|
| CC-122 | Drug | CC-122 |
|