Clinical trial: Food Effect and CYP1A2 Induction Study in Healthy Subjects (NCT02168205)

Eligibility criteria:
Inclusion Criteria:

          -  Part 1: 1.Must understand and voluntarily sign a written Informed Consent prior to any
             study-related 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.Must be male or postmenopausal* women of any race between ≥61 to ≤85 years of age
             (inclusive) at the time of signing the Informed Consent, and in good health as
             determined by a physical exam, clinical laboratory safety test results, vital signs,
             and 12 lead Electrocardiogram.

             * =Naturally postmenopausal for at least 24 consecutive months (ie, who has not had
             menses at any time in the preceding 24 consecutive months) 4.Subjects must be a non
             smoker. 5.Clinical laboratory tests must be within normal limits or acceptable to the
             Principal Investigator (PI).

             6.Must have a normal or clinically acceptable 12-lead Electrocardiogram. 7.Must be
             afebrile (febrile is defined as ≥ 38.0ºC or 100.4 Fahrenheit), with supine systolic
             blood pressure (BP): 90 to 150 mmHg, supine diastolic blood pressure: 60 to 95 mmHg,
             and pulse rate: 40 to 110 bpm and controlled on medications if they are indicated
             (especially for blood pressure).

               1. If a subject has a diagnosis of hypertension, the range for BP and pulse rate
                  will be the one that is considered well controlled on medication.

                  8.Must practice true abstinence* or agree to use a condom during sexual contact
                  with a pregnant female or a female that can get pregnant while participating in
                  the 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. Period abstinence (e.g., calendar, ovulation,
                  symptothermal, post ovulation methods) and withdrawal are not acceptable methods
                  of contraception 9.Must agree to refrain from donating sperm or semen while
                  participating in this study and for at least 28 days following the last dose of
                  study drug.

                  10.Must agree to refrain from donating blood or plasma (other than for this
                  study) while participating in this study and for at least 28 days following the
                  last dose of study drug.

                  11.Must agree to comply with the conditions described in the counseling document
                  (part of the pomalidomide Pregnancy Prevention Risk Management Plan.

                  Part 2

                    1. Must understand and voluntarily sign a written informed consent prior to any
                       study-related 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. Must be male of any race between 40 to 80 years of age (inclusive) at the
                       time of signing the Informed Consent, and in good health as determined by a
                       physical exam, clinical laboratory safety test results, vital signs, and 12
                       lead electrocardiogram.

                    4. Cohort A subjects (smokers) must have a history of smoking for >5 years and
                       currently smoke ≥1 pack (20-25) cigarettes per day; and urine cotinine level
                       at screening and baseline (Day -1) indicate subject is heavy smoker.

                    5. Cohort B subjects (non-smokers) must have not smoked for >5 years (Cohort
                       B).

                    6. Clinical laboratory tests must be within normal limits or acceptable to the
                       Principal Investigator.

                    7. Must have a normal or clinically acceptable 12-lead Electrocardiogram, with
                       a QTcF value ≤ 450 msec.

                    8. Must be afebrile (febrile is defined as ≥ 38.0ºC or 100.4 Fahrenheit), with
                       supine systolic blood pressure (BP): 90 to 150 mmHg, supine diastolic blood
                       pressure: 60 to 95 mmHg, and pulse rate: 40 to 110 bpm and controlled on
                       medications if they are indicated (especially for blood pressure).

                    9. Must practice true abstinence or agree to use a condom during sexual contact
                       with a pregnant female or a female that can get pregnant while participating
                       in the study, during dose interruptions and for at least 28 days following
                       study drug discontinuation, even if he has undergone a successful vasectomy.

                   10. Must agree to refrain from donating sperm or semen while participating in
                       this study and for at least 28 days following the last dose of study drug.

                   11. Must agree to refrain from donating blood or plasma (other than for this
                       study) while participating in this study and for at least 28 days following
                       the last dose of study drug.

                   12. Must agree to comply with the conditions described in the counseling
                       document (part of the pomalidomide Pregnancy Prevention Risk Management
                       Plan.

                  Exclusion Criteria:

          -  Both Parts:

               1. History of any clinically significant and relevant neurological,
                  gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary,
                  metabolic, endocrine, hematological, allergic disease, drug allergies, known
                  hypersensitivity to a member of the class of drugs that can modulate the immune
                  system, or other major disorders.

                    1. Subjects with well-controlled hypertension, hyperlipidemia, gout,
                       asthma/chronic obstructive pulmonary disease, hypothyroidism and other
                       common age-related disorders, requiring treatment and being well-controlled
                       on concomitant prescription medication(s) will be eligible for inclusion in
                       the study.

                    2. Subjects with diabetes, significant gastrointestinal diseases or hematologic
                       disorders should not be included in the study.

               2. Any condition, including the presence of laboratory abnormalities, 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.

               3. Used any prescribed systemic or topical medication within 30 days of the first
                  dose administration, unless these medications are chronically administered and
                  Sponsor agreement is obtained.

               4. Used any non-prescribed systemic or topical medication (including vitamin/mineral
                  supplements, and herbal medicines) within 14 days of the first dose
                  administration, unless these medications are chronically administered and Sponsor
                  agreement is obtained.

               5. Has any surgical or medical conditions possibly affecting drug absorption,
                  distribution, metabolism and excretion, e.g., bariatric procedure.

               6. Donated blood or plasma within 8 weeks before the first dose administration to a
                  blood bank or blood donation center.

               7. History of drug abuse (as defined by the current version of the Diagnostic and
                  Statistical Manual within 2 years before dosing, or positive drug screening test
                  reflecting consumption of illicit drugs.

               8. History of alcohol abuse (as defined by the current version of the DSM) within 2
                  years before dosing, or positive alcohol screen.

               9. 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
                  Immunodeficiency Virus antibodies at Screening.

              10. 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 is longer).

              11. Received vaccination (excluding seasonal flu vaccination) within 90 days of the
                  study drug administration.

              12. Subjects who are part of the staff personnel or family members of the
                  investigational study staff.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 80 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? Contradiction