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.
Phase:
Phase 1
Details
Lead Sponsor:
Celgene Celgene Corporation
Treatments:
Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination Pomalidomide Thalidomide