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Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01124851
First received: April 26, 2010
Last updated: June 30, 2011
Last verified: June 2011

April 26, 2010
June 30, 2011
August 2010
April 2011   (final data collection date for primary outcome measure)
  • Laboratory Tests [ Time Frame: Baseline period to end of 1-week treatment period. ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: Baseline period to end of 1-week treatment period. ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: Baseline period till 30 days after the last dose. ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: Baseline period to end of 1-week treatment period. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01124851 on ClinicalTrials.gov Archive Site
Maintenance Wakefulness Test [ Time Frame: Baseline period to end of 1-week treatment period. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Sleep Disorder
  • Drug: ABT-652
    See arm description for details
    Other Name: ABT-652
  • Drug: Placebo
    See arm description for details
    Other Name: Placebo
  • Experimental: Arm 1
    ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days
    Interventions:
    • Drug: ABT-652
    • Drug: Placebo
  • Experimental: Arm 2
    ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days
    Interventions:
    • Drug: ABT-652
    • Drug: Placebo
  • Experimental: Arm 3
    ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days
    Interventions:
    • Drug: ABT-652
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01124851
M11-685
No
Hana Florian, MD/Associate Medical Director, Abbott
Abbott
Not Provided
Not Provided
Abbott
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP