Effect of UV Exposure on the PD of Multiple Doses of CC-90001 and Pilot Food Effect Study
Completed
Celgene Corporation
Phase 1
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.
A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
Active, not recruiting
Celgene
Phase 2
This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled
study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory
pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with
placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis
(IPF). This study is designed to assess response to treatment by using measures of lung
function, disease progression, fibrosis on radiography, and patient-reported outcomes. It
will also assess dose response.
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