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ABT-384

Phase 2

Undisclosed | Small molecule | Other |Abbott Laboratories|Trials Updated: Dec 14, 2010

ABT-384 development status

Highest phase Phase 2 run by AbbVie (prior sponsor, Abbott) (NCT01137526)
Phase scored for ABTPhase 1
Registered trials 3 across 2 sponsors since Aug 2009

ABT-384 target and mechanism

Molecular targetHSD11B1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment40

FDA Designations

No designations recorded

ABT-384 clinical trials

ABT-384 · 2 trials · 1 indication

Phase 1 2
NCT01009216A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal FluidHealthy
COMPLETED12 Analytics
NCT00968422A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly SubjectsHealthy
COMPLETED28 Analytics
PHASE1COMPLETED
A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal Fluid
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Days -1 through 9
Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect)
Days 1, 4 through 9
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABT-384EXPERIMENTAL -
Low dose ABT-384EXPERIMENTAL -
Mid dose ABT-384EXPERIMENTAL -
High dose ABT-384EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ABT-384DRUGDoses will be administered daily for 5 days.
Matching placebo to ABT-384DRUGDoses will be administered daily for 21 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age is between 18 and 55 years * Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG Exclusion Criteria: * Use of protocol-prohibited medications within 2 weeks pr...

Countries:United States
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Frequently asked questions about ABT-384

What is ABT-384?

ABT-384 is an investigational small molecule drug developed by Abbott Laboratories. It is an inhibitor of the enzyme HSD11B1 and has been studied in Phase 1 clinical trials in healthy volunteers, including elderly subjects. Abbott Laboratories trades under the ticker ABT.

What does ABT-384 target?

ABT-384 targets HSD11B1, also known as 11-beta-hydroxysteroid dehydrogenase type 1. It acts as an inhibitor of this enzyme. HSD11B1 is the molecular target of the drug, and its inhibition is the mechanism studied in the clinical program.

Who makes ABT-384?

ABT-384 is developed by Abbott Laboratories, which trades under the ticker ABT. Abbott is the sponsor of the clinical trials conducted for this compound.

What phase is ABT-384 in?

ABT-384 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, and no trials are currently active.

What clinical trials is ABT-384 in?

ABT-384 has been studied in two completed Phase 1 trials. NCT01009216 measured ABT-384 levels and pharmacodynamic activity in cerebrospinal fluid in 12 healthy male volunteers. NCT00968422 evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in 28 elderly subjects aged 65 and older. Both trials were conducted in the United States.

How many patients were enrolled in ABT-384 trials?

The two completed Phase 1 trials of ABT-384 enrolled a total of 40 participants. NCT01009216 enrolled 12 healthy male volunteers, and NCT00968422 enrolled 28 elderly subjects. Both studies were randomized, double-blind, and placebo-controlled.