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ABT-652

Phase 1

Sleep Disorder | Small molecule | Psychiatry |Abbott Laboratories|Last Updated: Jul 4, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

ABT-652 · 1 trial · 1 indication

Phase 1 1
NCT01124851Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime SleepinessSleep Disorder
COMPLETED36 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
Sleep DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Maintenance Wakefulness Test
Baseline period to end of 1-week treatment period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days
Arm 2EXPERIMENTALABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days
Arm 3EXPERIMENTALABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days

Interventions

NameTypeDescription
ABT-652DRUGSee arm description for details
PlaceboDRUGSee arm description for details
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites5

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 certa...

Countries:United States
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Competitive Landscape -Insomnia and Sleep Disorders 11 trials (matched to "Sleep Disorder")

Frequently asked questions about ABT-652

What is ABT-652 used for?

ABT-652 is an investigational small molecule being developed for the treatment of sleep disorders, specifically excessive daytime sleepiness. It is in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes ABT-652?

ABT-652 is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT.

What phase is ABT-652 in?

ABT-652 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 trial has been completed to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.

What clinical trials is ABT-652 in?

ABT-652 has one completed Phase 1 clinical trial, NCT01124851, which studied the drug in 36 subjects with excessive daytime sleepiness in the United States. The trial was randomized, double-blind, and controlled.

Is ABT-652 FDA approved?

ABT-652 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it remains in clinical development and has not been authorized for marketing.