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ABT-102

Phase 1

Healthy Volunteers | Small molecule | Other |Abbott Laboratories|Last Updated: Nov 2, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

ABT-102 · 1 trial · 1 indication

Phase 1 1
NCT00854659A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy SubjectsHealthy Volunteers
COMPLETED36 Analytics
PHASE1COMPLETED
A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects
Healthy Volunteers
NCT0085465936
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Study Endpoints

Primary Endpoints

To determine the safety and tolerability of ABT-102 vs placebo in healthy adults.
10 days
To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults.
10 days

Secondary Endpoints

Exploratory analyses of Quantitive Thermosensory Testing (Warm Detection Threshold, Cold Detection Threshold, Warm Pain Threshold) done at peripheral and oral sites, will be done for ABT-102 and placebo treated subjects.
10 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORABT-102 Tablets, 4 mg BID
2ACTIVE_COMPARATORABT-102 Tablets BID, escalating dose
3ACTIVE_COMPARATORABT-102 Tablets BID, escalating dose
4PLACEBO_COMPARATORPlacebo Tablets, BID

Interventions

NameTypeDescription
ABT-102DRUGBID tablets, 7 days of treatment
PlaceboDRUGBID tablets, 7 days of treatment
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males and Females with a condition of general good health. * Must be willing to participate in all study-related procedures. Exclusion Criteria: * History of significant sensitivity to any drug. * Allergy to soy lecithin, soybeans, soybean oil, or other soybean derivatives. ...

Countries:United States
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Frequently asked questions about ABT-102

What is ABT-102 used for?

ABT-102 is an investigational small molecule being studied in healthy volunteers. It is being evaluated for safety, tolerability, and pharmacokinetics, meaning how the drug is absorbed, distributed, metabolized, and excreted in the body. It is not approved for any disease or condition and remains in clinical development.

Who makes ABT-102?

ABT-102 is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. The drug is an investigational small molecule currently in early-stage clinical development.

What phase is ABT-102 in?

ABT-102 is in Phase 1 clinical development. It is an investigational drug, meaning it is not FDA approved and is still being studied in clinical trials. The single completed Phase 1 trial evaluated the drug in healthy volunteers.

What clinical trials is ABT-102 in?

ABT-102 has one completed clinical trial, identified as NCT00854659, titled "A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects." This Phase 1 trial enrolled 36 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is ABT-102 the same as any other drug?

ABT-102 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is a small molecule being developed by Abbott Laboratories for research purposes in healthy volunteers.