NCT05758818

A Study of Milademetan Administration on Cardiac Repolarization in Healthy Subjects

A Randomized, Positive and Placebo-Controlled Trial to Evaluate the Effects of Milademetan Administration on Cardiac Repolarization in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Rain Oncology Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This will be a Phase 1, single-center, 2-part study in healthy subjects. Parts 1 and 2 need to be conducted in sequential order.

Detailed description

Part 1 will enroll up to 3 cohorts of 6 healthy adult subjects to receive a single dose. The total duration of participation from the Screening visit to the follow-up will be up to 7 weeks (up to 45 days). Part 2 of this study will randomize approximately 32 subjects. The total duration of participation from the Screening visit to the follow-up will be up to 8 weeks (up to 55 days).

Conditions

• Cardiac Repolarization

Interventions

Type	Name	Description
DRUG	Placebo	Participants will receive a single dose of placebo on Day 1, Day 8 or Day 15 of part 2
DRUG	Moxifloxacin (positive control)	Participants will receive a single dose of moxifloxacin on Day 1,Day 8, or Day 15 of Part 2
DRUG	Milademetan	Participants will receive a single dose of Milademetan on Day 1 for part 1 Participants will receive a single dose of milademetan on Day 1, Day 8, or Day 15 of Part 2

Timeline

• Start date: 2023-04-17
• Primary completion: 2023-06-08
• Completion: 2023-06-08
• First posted: 2023-03-07
• Last updated: 2023-08-08

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study