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

June 30, 2011 updated by: Abbott

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Site Reference ID/Investigator# 43241
    • California
      • Glendale, California, United States, 91206
        • Site Reference ID/Investigator# 38092
      • San Diego, California, United States, 92103
        • Site Reference ID/Investigator# 43264
    • New York
      • New York, New York, United States, 10019
        • Site Reference ID/Investigator# 40402
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Site Reference ID/Investigator# 38122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days
Drug: ABT-652
See arm description for details
Drug: Placebo
See arm description for details
Experimental: Arm 2
ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days
Drug: ABT-652
See arm description for details
Drug: Placebo
See arm description for details
Experimental: Arm 3
ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days
Drug: ABT-652
See arm description for details
Drug: Placebo
See arm description for details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Laboratory Tests
Time Frame: Baseline period to end of 1-week treatment period.
Baseline period to end of 1-week treatment period.
ECG
Time Frame: Baseline period to end of 1-week treatment period.
Baseline period to end of 1-week treatment period.
Adverse Events
Time Frame: Baseline period till 30 days after the last dose.
Baseline period till 30 days after the last dose.
Vital Signs
Time Frame: Baseline period to end of 1-week treatment period.
Baseline period to end of 1-week treatment period.

Secondary Outcome Measures

Outcome Measure
Time Frame
Maintenance Wakefulness Test
Time Frame: Baseline period to end of 1-week treatment period.
Baseline period to end of 1-week treatment period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

May 14, 2010

First Posted (Estimate)

May 17, 2010

Study Record Updates

Last Update Posted (Estimate)

July 4, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M11-685

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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