Clinical trial: A Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of a New Spray Dried Dispersion (SDD) Formulation of CC-11050 After Single Dose of CC-11050 and to Evaluate the Pharmacokinetics of CC-11050 Under Fasted and Fed Conditions and After Coadministration With Omeprazole (NCT04139226)

Eligibility criteria:
Inclusion Criteria:

        Subjects must satisfy the following criteria to be enrolled in the study:

          1. Subject is a male, or a non-pregnant and non-nursing female between 18 and 55 years,
             inclusive, of age at the time of signing the Informed Consent Form (ICF).

          2. Subject must understand and voluntarily sign an ICF prior to any study-related
             assessments/procedures being conducted.

          3. Subject is willing and able to adhere to the study visit schedule and other protocol
             requirements.

          4. Subject has a BMI ≥ 18 and ≤ 33 kg/m2 at screening.

          5. Female subject

               1. Must have a negative pregnancy test

               2. If postmenopausal: must have follicular stimulating hormone (FSH) test result >40
                  IU/L and a negative pregnancy test

          6. Contraception Requirements:

             Must comply with the following acceptable forms of contraception. All females of
             childbearing potential (FCBP) must use one of the approved contraceptive2 options
             described below while taking CC-11050 and for at least 28 days after administration of
             the CC-11050 dose. At the time of study entry, and at any time during the study when a
             FCFP's contraceptive measures or ability to become pregnant changes, the Investigator
             will educate the subject regarding contraception options and the correct and
             consistent use of effective contraceptive methods in order to successfully prevent
             pregnancy. A FCBP who engage in activity in which conception is possible must use one
             of the approved contraceptive options described below: Option 1: One highly effective
             method (eg, hormonal contraception [oral, injection, implant, transdermal patch,
             vaginal ring]; intrauterine device; tubal ligation; or partner's vasectomy) and 1
             additional form (latex condom or any nonlatex condom not made of natural [animal]
             membrane [eg, polyurethane], diaphragm, sponge).

             OR Option 2: Male or female condom (latex condom or non-latex condom NOT made out of
             natural [animal] membrane [for example, polyurethane) PLUS one additional barrier
             method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c)
             contraceptive sponge with spermicide.

          7. A male subject must:

             a. Practice true abstinence3 (which must be reviewed on a monthly basis and source
             documented) or agree to use a barrier method of birth control (condoms not made out of
             natural [animal] membrane [latex condoms are recommended]) during sexual contact with
             a pregnant female or female of FCBP while participating in the study, during dose
             interruptions, and for at least 28 days after the dose of IP, even if he has undergone
             a successful vasectomy.

          8. Subject has clinical laboratory safety test results that are within normal limits
             (WNL) or acceptable to the Investigator.

          9. Subject is afebrile (febrile is defined as ≥ 38°C or ≥100.4°F), with supine systolic
             blood pressure ≥ 90 and ≤ 150 mm Hg, supine diastolic blood pressure ≥ 50 and ≤ 90 mm
             Hg, and pulse rate ≥ 40 and ≤ 100 beats per minute at screening

         10. Subject is in good health as determined by past medical history, PE, vital signs,
             12-lead ECG, and clinical laboratory safety tests. Clinical laboratory safety tests
             (ie, hematology, chemistry, and urinalysis) and 12-lead ECGs must be WNL or clinically
             acceptable as judged by the Investigator.

         11. Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition:

               -  If male, the subject has a QTcF value ≤ 450 msec at screening

               -  If female, the subject has a QTcF value ≤ 470 msec at screening

        Exclusion Criteria:

        The presence of any of the following will exclude a subject from enrollment:

          1. Subject has any significant medical condition, laboratory abnormality, or psychiatric
             illness that would prevent the subject from participating in the study.

          2. Subject has any condition including the presence of laboratory abnormalities, which
             places the subject at unacceptable risk if he/she were to participate in the study.

          3. Subject has any condition that confounds the ability to interpret data from the study.

          4. Subject is pregnant or breastfeeding.

          5. Subject was exposed 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 was longer).

          6. Subject has used moderate or strong CYP3A4/5 inducers and/or inhibitors (including St.
             John's wort) within 30 days prior to dosing. The Indiana University P450 Drug
             Interactions Flockhart Table™ may be consulted for a list of such medications.

          7. Subject has any surgical or medical condition(s) possibly affecting drug absorption,
             distribution, metabolism, and excretion, eg, bariatric procedure. A subject with an
             appendectomy and/or cholecystectomy may be included.

          8. Subject has donated blood or plasma within 8 weeks before dose administration to a
             blood bank or blood donation center.

          9. Subject has a history of drug abuse (as defined by the current version of the
             Diagnostic and Statistical Manual) within 2 years before dose administration, or
             positive drug screening test reflecting consumption of illicit drugs unless positive
             drug screen is due to prescription drug use that is approved by the Investigator and
             the Medical Monitor.

         10. Subject has a history of alcohol abuse (as defined by the current version of the
             Diagnostic and Statistical Manual) within 1 year before dose administration, or a
             positive alcohol screen.

         11. Subjects smokes more than 10 cigarettes per day, or the equivalent in order tobacco
             products (self-reported).

         12. Subject has had a positive result to the test for human immunodeficiency virus (HIV)
             antibodies at Screening.

             • Chronic or resolved Hepatitis B or Hepatitis C are acceptable only if sequelae are
             limited to hepatic involvement and its consequent comorbidities. (ie, vasculitis,
             clinically significant globulinemia, etc. are unacceptable).

         13. Subject has received a live vaccination (excluding seasonal flu vaccination) within 30
             days of dosing.

         14. Used prescribed systemic or topic medication within 30 days of the first dose
             administration

         15. Used any non-prescribed systemic or topic medication (including vitamin/mineral
             supplements, and herbal medicines, eg, St. John's Wort) within 14 days of the first
             dose administration, unless Sponsor agreement is obtained.

         16. History of significant multiple and/or severe allergies (e.g., food, drug, latex
             allergy) or has had an anaphylactic reaction or significant intolerability to
             prescription or nonprescription drugs or.

         17. Subject is, for any reason, deemed by the Investigator to be inappropriate for this
             study, including a subject who is unable to communicate or to cooperate with the
             investigator or the clinical staff.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment