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A Phase 1 QT Study in Healthy Male Subjects

NCT01986894 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2019-11-12

No results posted yet for this study

Summary

This is a single-center, randomized, double-blind crossover study with four treatments, four periods and four sequences to investigate the effects of orally administered pomalidomide on QT interval. The study will be conducted in healthy male subjects. Pomalidomide (clinically indicated dose for multiple myeloma \[MM\] as per the United States Package Insert \[USPI\] of 4 mg and supratherapeutic dose of 20 mg) and placebo treatments will be double-blinded. Moxifloxacin (positive control) will be administered in an open-label fashion to determine the sensitivity of the assay. The core electrocardiogram (ECG) laboratory and ECG readers will be blinded to all study treatments and sequences.

Conditions

  • Clinical Pharmacology, Healthy Volunteer Study

Interventions

DRUG

Placebo

Single oral dose of Placebo

DRUG

Pomalidomide

Single oral dose of 4 mg pomalidomide

DRUG

Pomalidomide

Single oral dose of 20 mg pomalidomide

DRUG

Moxifloxacin

Single oral dose of 400 mg moxifloxacin tablet

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Edward O'Mara, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-18
Primary Completion
2013-12-02
Completion
2013-12-02

Countries

  • United States

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 NCT01986894 on ClinicalTrials.gov