Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
Condition: Excessive Sleepiness
MeSH terms: Disorders of Excessive Somnolence; Sleepiness
Intervention: armodafinil; armodafinil; placebo
Intervention description: 50 mg/day orally, once daily in the morning for 3 days; 150 mg/day orally, once daily in the morning for 3 days; placebo tablets, once daily in the morning for 3 days
Intervention MeSH terms: Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 427.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil
      and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag
      disorder.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  History of jet lag symptoms during the past 5 years.

          -  The subject is in good health, as determined by a medical and psychiatric history,
             medical examination, clinical laboratory test results, and electrocardiography (ECG)
             and physical examination findings.

          -  Women of childbearing potential must be abstinent or use a medically accepted method
             of contraception, and must continue use of this method for the duration of the study
             (and for 30 days after participation in the study).

          -  The subject is willing to comply with study restrictions and remain at the study
             center overnight, as required.

          -  The subject must agree to refrain from alcohol use during the study.

          -  The subject has a valid U.S. passport

        Key Exclusion Criteria:

          -  The subject has a history (past 12 months) or diagnosis of narcolepsy, obstructive
             sleep apnea/hypopnea syndrome (OSAHS), shift work sleep disorder (SWSD), or any other
             sleep disorder associated with excessive daytime sleepiness; or the subject has a
             history or current diagnosis of hypersomnia, insomnia, or sleep disorder.

          -  The subject has any serious acute or chronic cardiovascular, pulmonary,
             gastrointestinal, neurological, endocrine or renal illness (including diabetes
             mellitus), hepatitis, asthma, chronic obstructive pulmonary disease (COPD), or any
             other clinically relevant significant medical condition.

          -  The subject has a history of any cutaneous drug reaction or drug hypersensitivity, or
             any clinically significant hypersensitivity reaction, or multiple allergies.

          -  The subject has a history of deep vein thrombosis (DVT).

          -  The subject has known human immunodeficiency virus (HIV).

          -  The subject is pregnant or lactating.

          -  The subject has used nicotine within the last 3 months.

          -  The subject has a history of seizures, except for a single febrile seizure.

          -  The subject has a psychiatric disorder that would affect participation in the study or
             full compliance with study procedures.

          -  The subject has a clinically significant deviation from normal in clinical laboratory
             results, vital signs measurements, or physical examination findings.

          -  The subject used any prescription or over the counter drugs disallowed by the protocol
             within 7 days of screening visit 2 (i.e., stimulants, hypnotics).

          -  The subject has used an investigational drug within 1 month before the screening
             visit.

          -  The subject has any disorder that may interfere with drug absorption, distribution,
             metabolism, or excretion.

          -  The subject has a known hypersensitivity to armodafinil or modafinil, or any other
             component of the study drug tablets.