NCT03614455

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

An Open-label, Randomized, 2-period, 2-sequence Study to Evaluate the Single-dose Pharmacokinetics of Milademetan When Administered Alone or Concomitantly With Itraconazole or Posaconazole in Healthy Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Milademetan	Milademetan 100 mg capsule for oral administration
DRUG	Itraconazole	Itraconazole (200 mg) oral solution (20 mL of 10 mg/mL)
DRUG	Posaconazole	Posaconazole (200 mg) oral suspension (5 mL of 40 mg/mL)

Timeline

• Start date: 2018-07-13
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2018-08-03
• Last updated: 2019-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study