A Phase 1 QT Study in Healthy Male Subjects
Condition: Clinical Pharmacology, Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      A total of 72 male subjects will be randomized and enrolled, with 18 subjects assigned to
      each treatment sequence. For each treatment sequence, each subject will participate in a
      screening phase, four baseline phases, four treatment periods and a follow up visit. Within
      28 days prior to Period 1 dosing, subjects will sign an informed consent document (ICD) and
      undergo screening procedures to confirm eligibility. Qualifying subjects will return to the
      clinical site on Day -2 of Period 1 to begin baseline assessments, and will be domiciled at
      the clinical site from Day -2 to Day 2 of Period 1. For all remaining study periods, subjects
      will return to the clinical site on Day -1 to begin baseline assessments, and will be
      domiciled at the clinical site from Day -1 to Day 2. Subjects will be assigned randomly to
      one of four treatment sequences and will receive a single dose of the assigned treatment on
      Day 1 of each study period. There will be a minimum of 7 days and no more than 14 days
      between each dose.

      Subjects will begin an overnight fast of at least 8 hours prior to the start of continuous
      Holter monitoring on Day 1 (and Day 1 in Period 1). On the morning of Day 1 (and Day -1 in
      Period 1), continuous Holter monitoring for approximately 24 hours will be performed.
      Triplicate ECGs will be extracted for analysis at specific predose and postdose timepoints
      (or equivalent times on Day -1 of Period 1). Blood samples will be collected at pre specified
      timepoints for pharmacokinetic (PK) and clinical laboratory assessments. Safety will be
      monitored throughout the study.

      During each study period, subjects will be discharged from the clinical site on Day 2 upon
      satisfactory safety review and completion of the required study procedures. A safety follow
      up will be conducted by telephone 5 to 7 days following discharge in Period 4. In the event
      that a subject discontinues from the study, an early termination visit will be performed.
    

Intervention name(s): Placebo; Pomalidomide; Pomalidomide; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of Placebo; Single oral dose of 4 mg pomalidomide; Single oral dose of 20 mg pomalidomide; Single oral dose of 400 mg moxifloxacin tablet
Other intervention name(s): POMALYST®; POMALYST®; AVELOX®
Intervention MeSH terms: Moxifloxacin; Thalidomide; Pomalidomide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: TQT; Pharmacokinetic; Healthy