Eligibility Details:
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
1. Must understand and voluntarily sign a written informed consent form (ICF) prior to
any study-related assessments/procedures being performed.
2. Must be able to communicate with the Investigator, understand and comply with the
requirements of the study, and agree to adhere to restrictions and examination
schedules.
3. Be a healthy male or female of non-childbearing potential of any race, between 18 to
55 years of age (inclusive) at the time of signing the ICF, and in good health as
determined by the screening history and PE.
4. Agrees to abide by the requirements and restrictions outlined in the CC-92480
Pregnancy Prevention Plan for Subjects in Clinical Trials.
5. For males: Agree to use barrier contraception not made of natural (animal) membrane
(eg, latex or polyurethane condoms are acceptable) when engaging in sexual activity
with a female of childbearing potential (FCBP) 1 while on study medication, and for at
least 3 months after the last dose of study medication. 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 a plasma
follicle-stimulation hormone [FSH] level of > 40 IU/L at screening).
6. Must have a body mass index between 18 and 33 kg/m2 (inclusive) at the time of signing
the ICF.
7. No clinically significant laboratory test results as determined by the investigator.
8. At the screening visit, must be afebrile, with supine systolic BP: 90 to 140 mmHg,
supine diastolic BP: 50 to 90 mmHg, and pulse rate: 40 to 90 bpm. Eligibility criteria
for vital signs performed during check-in and/or predose on Day 1 will be at the
discretion of the Investigator. Repeat vital signs may be measured at Investigator
discretion.
9. Must have a normal or clinically-acceptable 12-lead ECG at screening. Male subjects
must have a corrected QT interval using Fridericia's formula (QTcF) value ≤ 430 msec.
Female subjects must have a QTcF value ≤ 450 msec.
10. Subject must agree and be willing to consume a standard high-fat meal (which may
contain gluten), for Part 2 subjects only.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
1. History of any clinically significant and relevant neurological, GI, renal, hepatic,
cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological,
allergic disease, drug allergies, or other major disorders as determined by the
Investigator.
2. Any condition that places the subject at unacceptable risk if he or she were to
participate in the study, or confounds the ability to interpret data from the study.
3. Use of any prescribed systemic or topical medication (including but not limited to
analgesics, anesthetics, etc) within 30 days of the first dose administration.
4. Use of any nonprescribed systemic or topical medication (including vitamin/mineral
supplements, and herbal medicines) within 14 days of the first dose administration.
5. Use of CYP3A inducers and inhibitors (including St. John's Wort) within 30 days of the
first dose administration.
6. Has any surgical or medical conditions possibly affecting drug absorption,
distribution, metabolism and excretion (ADME), eg, bariatric procedure. Appendectomy
and cholecystectomy are acceptable. Prior procedures of unclear ADME significance
should be reviewed with the Sponsor's Medical Monitor.
7. Donated blood or plasma within 8 weeks before the first dose administration to a blood
bank or blood donation center.
8. History of drug abuse (as defined by the current version of the Diagnostic and
Statistical Manual [DSM]) within 2 years before dosing, or positive drug screening
test reflecting consumption of illicit drugs.
9. History of alcohol abuse (as defined by the current version of the DSM) within 2 years
before dosing, or positive alcohol screen.
10. Known to have serum hepatitis; known to be a carrier of the hepatitis B surface
antigen (HBsAg), hepatitis B surface antibody (anti-HBs), hepatitis B core antibody
(anti-HBc), or hepatitis C antibody (HCV Ab); have a positive result to the test for
hepatitis B or hepatitis C virus at screening or have a positive result to the test
for human immunodeficiency virus (HIV) antibodies at screening. Subjects whose results
are compatible with prior immunization against hepatitis B may be included at the
discretion of the Investigator.
11. Exposure to an investigational drug (new chemical entity) within 30 days preceding the
first dose administration, or 5 half-lives of that investigational drug, if known
(whichever is longer).
12. Use of tobacco- or nicotine-containing products within 3 months prior to Day -1
(Period 1 for Part 2).
13. Vaccination within 30 days of dosing or plans to receive vaccination within 30 days
after dosing.
14. Systemic infection within 30 days of dosing.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
