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NCT01733875

2-part Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of CC-220 & Effect of Food on CC-220 in Healthy Subjects

Completed Phase 1 Last updated 12 November 2019
What this trial tests

Phase 1 trial testing CC-220 0.03 mg in Healthy in 65 participants. Completed in 9 October 2013.

Timeline
1 November 2012
Primary endpoint
9 October 2013
9 October 2013

Quick facts

Lead sponsorCelgene
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposeother
Enrollment65
Start date1 November 2012
Primary completion9 October 2013
Estimated completion9 October 2013
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Celgene — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of CC-220 and to explore the effect of food on the bioavailability of CC-220 in healthy subjects

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Novel immunomodulatory drugs and neo-substrates.
    Gao S, Wang S, Song Y. · · 2020 · cited 64× · PMID 31938543 · DOI 10.1186/s40364-020-0182-y
  2. Cereblon modulator iberdomide induces degradation of the transcription factors Ikaros and Aiolos: immunomodulation in healthy volunteers and relevance to systemic lupus erythematosus.
    Schafer PH, Ye Y, Wu L, Kosek J, et al · · 2018 · cited 61× · PMID 29945920 · DOI 10.1136/annrheumdis-2017-212916
  3. First-in-Human, Single- and Multiple-Ascending-Dose Studies in Healthy Subjects to Assess Pharmacokinetics, Pharmacodynamics, and Safety/Tolerability of Iberdomide, a Novel Cereblon E3 Ligase Modulator.
    Ye Y, Gaudy A, Schafer P, Thomas M, et al · · 2021 · cited 21× · PMID 32969202 · DOI 10.1002/cpdd.869
  4. Ikaros Proteins in Tumor: Current Perspectives and New Developments.
    Xia R, Cheng Y, Han X, Wei Y, et al · · 2021 · cited 12× · PMID 34950704 · DOI 10.3389/fmolb.2021.788440
  5. Molecular glue degrader for tumor treatment.
    Hu Y, Yan Y, Wang J, Hou J, et al · · 2024 · cited 8× · PMID 39759140 · DOI 10.3389/fonc.2024.1512666

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Other recruiting trials for Healthy

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Other Celgene trials

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing