Back to resultsSafety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
Primary Purpose
Sleep Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABT-652
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disorder focused on measuring Sleep disorder
Eligibility Criteria
Inclusion Criteria
- Has current diagnosis of an excessive daytime sleepiness disorder, including narcolepsy, idiopathic hypersomnia, and obstructive sleep apnea
- Age 18 to 60 years Exclusion Criteria
- Has significant suicidal ideation
- Has a history of substance abuse
- Has a history of a certain significant medical conditions, including uncontrolled psychiatric diseases or disorders
- Use of certain medications
Sites / Locations
- Site Reference ID/Investigator# 43241
- Site Reference ID/Investigator# 38092
- Site Reference ID/Investigator# 43264
- Site Reference ID/Investigator# 40402
- Site Reference ID/Investigator# 38122
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days
ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days
ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days
Outcomes
Primary Outcome Measures
Laboratory Tests
ECG
Adverse Events
Vital Signs
Secondary Outcome Measures
Maintenance Wakefulness Test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01124851
Brief Title
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
Official Title
A Multiple Dose Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ABT-652 Administered Once Daily to Subjects With an Excessive Daytime Sleepiness Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652 given once daily to people with excessive daytime sleepiness. Subjects will be randomized to either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
Keywords
Sleep disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days
Intervention Type
Drug
Intervention Name(s)
ABT-652
Intervention Description
See arm description for details
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
See arm description for details
Primary Outcome Measure Information:
Title
Laboratory Tests
Time Frame
Baseline period to end of 1-week treatment period.
Title
ECG
Time Frame
Baseline period to end of 1-week treatment period.
Title
Adverse Events
Time Frame
Baseline period till 30 days after the last dose.
Title
Vital Signs
Time Frame
Baseline period to end of 1-week treatment period.
Secondary Outcome Measure Information:
Title
Maintenance Wakefulness Test
Time Frame
Baseline period to end of 1-week treatment period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Has current diagnosis of an excessive daytime sleepiness disorder, including narcolepsy, idiopathic hypersomnia, and obstructive sleep apnea
Age 18 to 60 years Exclusion Criteria
Has significant suicidal ideation
Has a history of substance abuse
Has a history of a certain significant medical conditions, including uncontrolled psychiatric diseases or disorders
Use of certain medications
Facility Information:
Facility Name
Site Reference ID/Investigator# 43241
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Site Reference ID/Investigator# 38092
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Site Reference ID/Investigator# 43264
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Site Reference ID/Investigator# 40402
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Site Reference ID/Investigator# 38122
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
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