NCT02321644

Effect of UV Exposure on the PD of Multiple Doses of CC-90001 and Pilot Food Effect Study

A Two-Part, Phase 1 Study to Evaluate Pharmacokinetics and Pharmacodynamics of Multiple Dose CC-90001 and to Evaluate the Effects of Food and Formulation on Pharmacokinetics of Single Dose CC-90001 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Celgene Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	CC-90001	CC-90001 Active-ingredient-in-capsule and formulated tablet

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-12-22
• Last updated: 2015-08-19

Locations

2 sites across 1 country: United States