CC-223 and Ketoconazole Drug-Drug Interaction Study

This is a 2 period study, which lasts about 6 weeks long. About 14 males will be entered into the study, during which they will receive the study drug (a single dose of 20 mg CC-223) 400 mg ketoconazole.

Inclusion criteria

• Must understand and voluntarily sign a written informed consent form before participation.
• Must be able to communicate with the study doctor, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
• Healthy male subject of any race between 18 to 65 years of age, and in good health as determined by a physical examination.

• For males: Agree to use barrier contraception not made of natural (animal) membrane (for example, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of child-bearing potential while on study medication, and for at least 28 days after the last dose of study medication.
• Must have a body mass index between 18 and 33 kilograms/meter squared.
• Clinical laboratory tests must be within normal limits or acceptable to the study doctor.
• Must not have a fever, with a blood pressure between 90/50 to 140/90 millimeters of mercury, and pulse rate: between 40 to 110 beats per minute.
• Must have a normal or clinically acceptable 12-lead electrocardiogram.

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.
• Any condition which places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
• Used any prescribed or topical medication within one month before the first dose of study drug, unless consultation between the sponsor and the study doctor.
• Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 2 weeks (30 days for St. John's Wort®) of the first dose administration, unless sponsor agreement is obtained.
• Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion of the study drug, for example, bariatric procedure.
• Donated blood or plasma within 2 months before the first dose of study drug.
• History of drug abuse within 2 years before dosing, or a positive drug screening test reflecting consumption of illicit drugs.
• History of alcohol abuse within 2 years before dosing, or positive alcohol screen.
• Known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen, or hepatitis C antibody, or have a positive result to the test for Human Immune virus antibodies at Screening.
• Exposed to an investigational drug within one month 30 days before the first dose of study drug.
• Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products.