Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Intervention: SPD489 20 mg; SPD489 50 mg; SPD489 70 mg; Armodafinil; Placebo
Intervention description: Single oral dose of 20 mg; Single oral dose of 50 mg; Single oral dose of 70 mg; Single oral dose of 250 mg; Single oral dose
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a double-blind, single center, parallel group, placebo and active comparator,
      controlled study to characterize the wake promoting effects of single doses of SPD489 in
      healthy adult male undergoing acute sleep deprivation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects between the ages of 18-40 years.

          -  The subject is in good health and must have a satisfactory medical assessment with no
             clinically significant and relevant abnormalities (of medical history, physical
             examination, electrocardiogram (ECG), clinical laboratory evaluation (hematology,
             biochemistry, and urinalysis).

          -  Subject has a history of regular sleep-wake habits, routinely spending 6.5-8 hours in
             bed nightly, and does not oversleep by more than 3 hours on weekends.

          -  Subject has the ability to provide written, signed, and dated (personally) informed
             consent to participate in the study, in accordance with the International Conference
             on Harmonisation Good Clinical Practice Guideline E6 and applicable regulations,
             before completing any study-related procedures.

        Exclusion Criteria:

          -  Current or relevant previous history of serious, severe, or unstable (acute or
             progressive) physical or psychiatric illness, any medical disorder that may require
             treatment or make this subject unlikely to fully complete the study, or any condition
             that presents undue risk from SPD489 or armodafinil or procedures. Comorbid
             psychiatric diagnosis will be established by a psychiatric evaluation that includes
             the Mini International Neuropsychiatric Interview (MINI)-Plus.

          -  Subject is currently considered a suicide risk, has previously made a suicide attempt,
             or has a prior history of, or is currently demonstrating suicidal ideation.

          -  Subject has a known or suspected sleep disorder, or another disorder associated with
             excessive daytime sleepiness, or any other diagnosis that would interfere with
             assessing sleepiness in subjects with study related induced sleepiness or abnormal
             findings on the initial PSG conducted on Day -1 such as, but not limited to,
             Apnea-Hypopnea Index (AHI) or Periodic Limb Movement Arousal Index (PLMAI) >10.