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Ibrutinib DDI Study with Oral Contraceptives and CYP Substrates
NCT03301207Phase 1Completed
- Sponsor
- Janssen Pharmaceutical
- Start
- Oct 2017
- Primary completion
- Jul 2018
- Modality
- Small Molecules
- Countries
- 2
01
Overview
Phase 1, open-label, single-arm trial of ibrutinib in chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL) and 2 more, sponsored by Janssen Pharmaceutical. Primary endpoints: Maximum Observed Plasma Concentration (Cmax) of Ethinylestradiol (EE) and Levonorgestrel (LN) at Day 22, Maximum Observed Plasma Concentration (Cmax) of Bupropion and 4-Hydroxybupropion at Day 24 and 4 more. Started Oct 2017; status: completed.
02
Drugs
ibrutinib
03
Conditions
chronic lymphocytic leukemia (CLL)small lymphocytic lymphoma (SLL)marginal zone lymphoma (MZL)mantle cell lymphoma (MCL)Waldenstrom macroglobulinemia (WM)
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