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. |
| NCT03363815 ↗ | A Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects | Completed | Celgene | Phase 1 | This is a four-part study to evaluate the effect of multiple doses of CC-90001 on the PK, safety, and tolerability of single doses of omeprazole, midazolam, warfarin, rosuvastatin, metformin, digoxin, and nintedanib in healthy subjects. Each study part is a nonrandomized, fixed-sequence, open-label, two-period study. The study parts can be run in any order and can be, but do not have to be, run in parallel. Subjects may participate in one part only. For each part, each subject will participate as follows: - Screening (Days -21 through -2) - Baseline phase for each study period (Periods 1 and 2) - Treatment phase for each study period (Periods 1 and 2) - Follow-up telephone call |
| NCT03742882 ↗ | A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects | Completed | Celgene | Phase 1 | This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Child-Pugh Classification Criteria. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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