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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01124851

Enrollment

Registered

2010-05-17

Start date

2010-08-31

Completion date

2011-04-30

Last updated

2011-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorder

Keywords

Sleep 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.

Interventions

DRUGABT-652

See arm description for details

DRUGPlacebo

See arm description for details

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Maintenance Wakefulness Test	Baseline period to end of 1-week treatment period.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026