drugset
drugset / Trial / NCT02122770

Effects of Fluconazole and Itraconazole CYP3A-Mediated Inhibition on the Pharmacokinetics, Safety, and Tolerability of MLN4924 in Participants With Advanced Solid Tumors

NCT02122770 ↗

Phase 1 Completed 51 enrolled Millennium Pharmaceuticals, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of this study is to assess the effect of multiple-dose administration of fluconazole on the single-dose intravenous (IV) pharmacokinetics (PK) of MLN4924; and to assess the effect of multiple-dose administration of itraconazole on the single-dose IV PK of MLN4924.

Timeline

Start
2014-04-01
Primary completion
2017-06-05
Completion
2017-06-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluconazole Small molecule 200 mg —
Subject Itraconazole Small molecule 200 mg Oral
Subject Pevonedistat Small molecule 8 mg/m2 Intravenous
Subject Pevonedistat Small molecule 15 mg/m2 Intravenous
Subject Pevonedistat Small molecule 20 mg/m2 Intravenous
Background Carboplatin Small molecule — Intravenous
Background Docetaxel Small molecule — Intravenous
Background Paclitaxel Small molecule — Intravenous

Indications

No indication recorded.