Phase I Open-Label Two-Part Study To Evaluate The Effect Of Food and Of CYP1A2 Induction On Pomalidomide (CC-4047) Pharmacokinetics in Healthy Subjects

Trial Profile

Phase I Open-Label Two-Part Study To Evaluate The Effect Of Food and Of CYP1A2 Induction On Pomalidomide (CC-4047) Pharmacokinetics in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 15 May 2018

At a glance

  • Drugs Pomalidomide (Primary)
  • Indications Multiple myeloma; Myelofibrosis; Systemic scleroderma; Waldenstrom's macroglobulinaemia
  • Focus Pharmacokinetics
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 15 May 2018 Results assessing effect of CYP1A2 inhibition by fluvoxamine (a strong CYP1A2 inhibitor) and CYP1A2 induction by smoking on pomalidomide pharmacokinetics in healthy subjects has been assessed in 2 separate phase 1 (CC-4047-CP-011 and CC-4047-CP-012) open-label, single-dose studies, were published in the Journal of Clinical Pharmacology.
    • 05 Oct 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
    • 25 Jun 2014 New trial record
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