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

Phase 1

Completed

• Conditions: Sleep Disorder
• Interventions: Drug: ABT-652; Drug: Placebo

• Registration Number: NCT01124851
• Lead Sponsor: Abbott

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 available

Study Timeline

• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-05-14
• Study First Posted: 2010-05-17
• Study Start: 2010-08
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	ABT-652	ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days
Arm 1	Placebo	ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days
Arm 2	ABT-652	ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days
Arm 2	Placebo	ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days
Arm 3	ABT-652	ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days
Arm 3	Placebo	ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maintenance Wakefulness Test	Baseline period to end of 1-week treatment period.

Trial Locations

Locations (5)

Site Reference ID/Investigator# 43241; 🇺🇸 Phoenix, Arizona, United States

Site Reference ID/Investigator# 38092; 🇺🇸 Glendale, California, United States

Site Reference ID/Investigator# 43264; 🇺🇸 San Diego, California, United States

Site Reference ID/Investigator# 40402; 🇺🇸 New York, New York, United States

Site Reference ID/Investigator# 38122; 🇺🇸 Durham, North Carolina, United States