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ABT-652

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01124851Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime SleepinessPHASE1 COMPLETED 36Aug 1, 2010Apr 1, 2011Jul 4, 20115 United States
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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 — 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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