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A Study of Milademetan Administration on Cardiac Repolarization in Healthy Subjects

NCT05758818 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-08-08

No results posted yet for this study

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.

Conditions

  • Cardiac Repolarization

Interventions

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

Sponsors & Collaborators

  • Rain Oncology Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2023-06-08
Completion
2023-06-08
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05758818 on ClinicalTrials.gov