NCT03647202

Food Effects on Milademetan Pharmacokinetics in Healthy Participants

An Open-label, Randomized, 3-period, 3-treatment Crossover Study to Evaluate the Effect of High-fat, High-calorie Food and Standard Food on the Single-dose Pharmacokinetics of Milademetan in Healthy Subjects

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

Summary

The primary objectives of this trial are: * To evaluate the effect of a high-calorie, high-fat meal on the single-dose pharmacokinetics (PK) of milademetan * To evaluate the effect of a standard meal on the single-dose PK of milademetan The key secondary objective is to evaluate the safety and tolerability of single-dose milademetan in all treatments. The duration of the study for each individual participant will be approximately 8 weeks from the start of Screening (within 28 days prior to dosing of study drug on Day 1) through the final Follow-up visit or phone call. Participants will remain in the Clinical Research Unit (CRU) from Study Day -2 through Study Day 20 (a total of 22 days and 21 nights). Participants will receive 3 single doses of study drug (at least 1 week apart) over the course of 15 days. At the investigator's discretion, participants may be asked to return to the CRU 14 days (±2 days) after final dose of study drug for a follow-up visit. The end of the study is defined as the date of final follow-up visit of the last subject undergoing the study.

Conditions

• Food Effects on Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Milademetan Treatment A	Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions
DRUG	Milademetan Treatment B	Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
DRUG	Milademetan Treatment C	Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.

Timeline

• Start date: 2018-08-16
• Primary completion: 2018-09-13
• Completion: 2018-09-13
• First posted: 2018-08-27
• Last updated: 2019-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study