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NCT03340662

Study Evaluating the Effects of Food, Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of CC-122

Completed Phase 1 Last updated 16 January 2019
What this trial tests

Phase 1 trial testing CC-122 in Healthy Volunteer in 81 participants. Completed in 27 January 2018.

Timeline
9 November 2017
Primary endpoint
27 January 2018
27 January 2018

Quick facts

Lead sponsorCelgene
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment81
Start date9 November 2017
Primary completion27 January 2018
Estimated completion27 January 2018
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 Volunteer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 1 open-label 4-part study to evaluate the effect of food, cytochrome P450 inhibition and induction on the pharmacokinetics of CC 122 in healthy adult subjects. Approximately 81 subjects will be enrolled. There will be approximately 24 subjects in Part 1 and approximately 19 subjects in Parts 2, 3, and 4, respectively. Subjects may participate in 1 part only.

Publications & conference data

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

  1. Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
    Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
  2. Drug-Drug Interaction Study to Assess the Effect of Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of the Novel Cereblon Modulator Avadomide (CC-122) in Healthy Adult Subjects.
    Ogasawara K, MacGorman K, Liu L, Chen J, et al · · 2019 · cited 5× · PMID 31172535 · DOI 10.1002/jcph.1453

Verify or expand the search:

Other trials of CC-122

Trials testing the same drug.

Other recruiting trials for Healthy Volunteer

Currently open trials in the same condition.

Other Celgene trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03340662.

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