Effect of UV Exposure on the PD of Multiple Doses of CC-90001 and Pilot Food Effect Study
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part, phase 1 study to evaluate the pharmacokinetics and pharmacodynamics of
      multiple doses of CC-90001 and the effects of food and formulation on the pharmacokinetics of
      single dose CC-90001 in healthy subjects. Part 1 involves the exposure of subjects to the
      minimum amount of UV-B light that causes minimally perceptible skin reddening. This will take
      place before dosing (baseline) and 3 times more while on increasing doses of CC-90001. Punch
      biopsies of the exposed areas will be taken and assessed for c-Jun terminal kinase activity.
      Part 2 involves evaluation of changes in pharmacokinetics of 2 formulations of CC-90001 when
      administered in the fasted state and after a high-fat meal.
    

Detailed description: 
      Part 1 is an open-label, multiple-dose, 3-period, fixed-sequence study, to evaluate the
      effect of CC-90001 on JNK activity following UV irradiation. On the first day prior to dosing
      (baseline), and on the 6th day of each dosing period (Days 6, 12, and 18), twice the MED
      intensity of UV light will be administered to delineated sites on the subjects' buttocks. The
      irradiation at baseline (Day -1) should be administered at approximately the same time that
      irradiation is scheduled on Days 6, 12, and 18, which is at 2 hours post dose. Eight hours
      after UV irradiation, a skin punch biopsy will be taken from the UV exposure site. The end of
      confinement will be Day 19. The follow-up visit will occur 7-10 days (ie, Day 25 to Day 28)
      following the last dose in Period 3. An early termination (ET) visit will occur within 10
      days of the day of discontinuation. The MED will be determined within 10 days of dosing in
      Period 1. All subjects will receive the following doses of CC-90001 in the fixed sequence
      below: Treatment A: 60 mg CC-90001 as AIC, QD x 6 days; Treatment B: 160 mg CC-90001 as AIC,
      QD x 6 days; and Treatment C: 400 mg of CC-90001 as AIC, QD x 6 days. Subjects will be
      confined at the unit from Day -1 until discharge on Day 19 after all safety assessments.

      In Part 2 subjects will be assigned randomly to one of three dosing sequences during which
      they will receive one of the following dosing regimens:

        -  Treatment D: 2 x 100 mg CC-90001 as AIC, single oral dose administered under fasted
           conditions.

        -  Treatment E: 1 x 200 mg CC-90001 [formulated tablet(s)] single oral dose administered
           under fasted conditions

        -  Treatment F: 1 x 200 mg CC-90001 [formulated tablet(s)] single oral dose administered
           under fed conditions (standard high fat breakfast).
    

Intervention name(s): CC-90001
Intervention type(s): Drug
Intervention description(s): CC-90001 Active-ingredient-in-capsule and formulated tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CC-90001; PHARMACOKINETICS; PHARMACODYNAMICS; HEALTHY SUBJECTS; SINGLE DOSE; MULTIPLE DOSE; PUNCH BIOPSY