drugset / Trial / NCT03614455
Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.