drugset / Trial / NCT02321644
Effect of UV Exposure on the PD of Multiple Doses of CC-90001 and Pilot Food Effect Study
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-11
- Primary completion
- 2015-02
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CC-90001 | Small molecule | 60 mg | Oral |
| Subject | CC-90001 | Small molecule | 160 mg | Oral |
| Subject | CC-90001 | Small molecule | 200 mg | Oral |
| Subject | CC-90001 | Small molecule | 400 mg | Oral |
Indications
No indication recorded.