drugset / Trial / NCT03614455

Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants

NCT03614455

Phase 0 Completed 36 enrolled Daiichi Sankyo
RandomizedSequentialOpen-labelBasic science

Summary

This will be an open-label, randomized, 3-treatment, 2-period, 2-sequence study in healthy subjects to evaluate the single-dose PK of milademetan when given as monotherapy and when administered with steady-state levels of the strong CYP3A4 inhibitors itraconazole or posaconazole. The duration of the study for each individual subject will be approximately 49 days from the start of Screening through Study Discharge. Subjects will remain in-house for up to 23 days, including 22 overnight stays.

Timeline

Start
2018-07-13
Primary completion
2018-10-01
Completion
2018-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Milademetan Small molecule 100 mg Oral
Background Itraconazole Small molecule 200 mg Oral
Background Posaconazole Small molecule 200 mg Oral

Indications

No indication recorded.