This will be a single-center, 2-part, open-label, randomized (Part 1 only), 2-treatment study in healthy adult males (n = 18). Within no more than 28 days (Day -28) prior to the start of Part 1 or Part 2, subjects will undergo routine screening procedures including physical examination, 12-lead electrocardiograms (ECGs), vital signs, clinical laboratory safety tests (serum chemistry, hematology, and urinalysis), serology screen, fasting glucose levels (including HbA1C) and drug and alcohol screen.~In Part 1, subjects (n = 6) will receive Treatment A (Cohort 1) under fasted conditions. Treatment A: A single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]- CC-223 solution. For Part 1, subjects will be domiciled at the study center from Day -1 until the morning of Day 8. Upon satisfactory safety review and completion of study-related procedures, subjects will be discharged from the study center on the morning of Day 8.~Part 2 will be a 2-period crossover study; in Period 1, subjects (n = 12) will be randomized to receive an oral 20 mg dose of CC-223 (Treatment B) under fed (n = 6) or fasted (n = 6) conditions. In Period 2, subjects will receive Treatment B under converse conditions based on treatment assignment in Period 1 (Cohort 2 or 3). Fed subjects will be served a standard high fat meal (breakfast), or its equivalent, and must be consumed within 30 minutes of serving. Dosing must occur 30 minutes (±5 minutes) after serving a subject breakfast. All subjects will remain fasted until 4 hours post dose. Subjects will be domiciled at the study center from Day -1 until the morning of Day 5 of each period. Subjects will be discharged from the study center on the morning of Day 5 upon satisfactory safety review and completion of study-related procedures. Periods 1 and 2 will be separated by a washout period of at least 7 days (no more than 10 days) from prior dose to the next dose. In certain instances, a longer washout may be acceptable if previously agreed to by the principal investigator (PI) and Celgene.~All subjects will return to the clinic within 7 to 10 days after the day of discharge in Part 1 or Period 2 of Part 2 for follow-up safety assessments.
Part 1: To characterize the biotransformation and excretion of CC-223 following a single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male subjects; and to evaluate the tolerability of CC-223 after a single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male adult subjects Part 2: To evaluate the effect of a high-fat meal on the pharmacokinetics (PK) of CC-223 following a single 20-mg oral dose of CC-223 tablet; To evaluate the effect of a high-fat meal on the PK of M1, the principal pharmacologically-active metabolite, following a single 20-mg oral dose of CC-223 tablet; and to evaluate the tolerability of CC-223 after a single 20-mg oral dose of CC-223 tablet in healthy male adult subjects.