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ABT-384

Phase 1

Healthy | Small molecule | Other |Abbott Laboratories|Last Updated: Dec 14, 2010

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

Clinical trial landscape

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 being developed by Abbott Laboratories. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, including elderly subjects, to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.

What is ABT-384 used for?

ABT-384 is being studied for use in healthy volunteers. It has not been approved for any medical condition. The clinical trials focus on evaluating the drug's safety, tolerability, and how it behaves in the body, rather than treating a specific disease.

Who makes ABT-384?

ABT-384 is being developed by Abbott Laboratories, a company traded under the ticker symbol ABT. The drug is currently in Phase 1 clinical trials, which are being conducted in the United States.

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 regulatory authorities. Two Phase 1 trials have been completed, involving a total of 40 healthy participants.

What clinical trials is ABT-384 in?

ABT-384 has two completed Phase 1 trials. NCT00968422 studied the drug in elderly subjects, enrolling 28 participants. NCT01009216 measured drug levels and pharmacodynamic activity in cerebrospinal fluid, enrolling 12 male participants. Both trials were conducted in the United States.

Is ABT-384 the same as any other drug?

ABT-384 is the only name provided for this drug. No alternative names have been associated with it in the available information. It is a distinct investigational compound developed by Abbott Laboratories.