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

NCT ID: NCT01096680

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-05
• Study Completion Date: 2010-07-18

Brief 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.

Conditions

Sleep Deprivation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

SPD489 20 mg

Group Type: EXPERIMENTAL

SPD489 20 mg

Intervention Type: DRUG

Single oral dose of 20 mg

SPD489 50 mg

Group Type: EXPERIMENTAL

SPD489 50 mg

Intervention Type: DRUG

Single oral dose of 50 mg

SPD489 70 mg

Group Type: EXPERIMENTAL

SPD489 70 mg

Intervention Type: DRUG

Single oral dose of 70 mg

Armodafinil

Group Type: ACTIVE_COMPARATOR

Armodafinil

Intervention Type: DRUG

Single oral dose of 250 mg

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single oral dose

Interventions

SPD489 20 mg

Single oral dose of 20 mg

Intervention Type: DRUG

SPD489 50 mg

Single oral dose of 50 mg

Intervention Type: DRUG

SPD489 70 mg

Single oral dose of 70 mg

Intervention Type: DRUG

Armodafinil

Single oral dose of 250 mg

Intervention Type: DRUG

Placebo

Single oral dose

Intervention Type: DRUG

Other Intervention Names

Vyvanse; Vyvanse; Vyvanse

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Clinilabs, Inc.

New York, New York, United States

Countries

United States

Other Identifiers

SPD489-207

Identifier Type: -

Identifier Source: org_study_id