Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Celgene Corporation
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).
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
