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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 26, 2010
Last Updated Date	June 30, 2011
Start Date ^ICMJE	August 2010
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 14, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01124851 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 14, 2010)	Maintenance Wakefulness Test [ Time Frame: Baseline period to end of 1-week treatment period. ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Sleep Disorder
Intervention ^ICMJE	Drug: ABT-652 See arm description for details Other Name: ABT-652 Drug: Placebo See arm description for details Other Name: Placebo
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	36
Completion Date	April 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01124851
Other Study ID Numbers ^ICMJE	M11-685
Has Data Monitoring Committee	No
Responsible Party	Hana Florian, MD/Associate Medical Director, Abbott
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Abbott
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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