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

Abbott

Status and phase: Completed; Phase 1

Conditions: Sleep Disorder

Treatments: Drug: Placebo; Drug: ABT-652

Study type: Interventional

Funder types: Industry

Identifiers

NCT01124851

M11-685

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 3 patient groups

Arm 1

Experimental group

Description:

ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days

Treatment:

Drug: ABT-652

Drug: Placebo

Arm 2

Experimental group

Description:

ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days

Treatment:

Drug: ABT-652

Drug: Placebo

Arm 3

Experimental group

Description:

ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days

Treatment:

Drug: ABT-652

Drug: Placebo