CLINICAL TRIALS PROFILE FOR CC-90001
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Clinical Trials for CC-90001
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT02110420 ↗ | First-in-human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001 | Completed | Celgene Corporation | Phase 1 | First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of CC-90001 |
| NCT02321644 ↗ | 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. |
| NCT02510937 ↗ | Safety and PK Study of CC-90001 in Subjects With Pulmonary Fibrosis | Completed | Celgene | Phase 1 | Participation in the study will last for 3months, with a 1 month screening phase. |
| NCT02510937 ↗ | Safety and PK Study of CC-90001 in Subjects With Pulmonary Fibrosis | Completed | Celgene Corporation | Phase 1 | Participation in the study will last for 3months, with a 1 month screening phase. |
| NCT03142191 ↗ | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for CC-90001
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Clinical Trial Locations for CC-90001
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Clinical Trial Progress for CC-90001
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Clinical Trial Sponsors for CC-90001
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