Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss

Shire

Status and phase: Completed; Phase 2

Conditions: Sleep Deprivation

Treatments: Drug: Placebo; Drug: SPD489 20 mg; Drug: SPD489 50 mg; Drug: Armodafinil; Drug: SPD489 70 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01096680

SPD489-207

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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135 participants in 5 patient groups, including a placebo group

SPD489 20 mg

Experimental group

Treatment:

Drug: SPD489 20 mg

SPD489 50 mg

Experimental group

Treatment:

Drug: SPD489 50 mg

SPD489 70 mg

Experimental group

Treatment:

Drug: SPD489 70 mg

Armodafinil

Active Comparator group

Treatment:

Drug: Armodafinil

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo