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ABT-102

Phase 1

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

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2009

Target and mechanism

Molecular targetTRPV1
Target classAntagonist
ModalitySmall molecule

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
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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?

ABT-102 is an investigational small molecule developed by Abbott Laboratories. It was studied in a Phase 1 clinical trial in healthy adult volunteers to evaluate its safety, tolerability, and pharmacokinetics. It is not an approved medicine and remains in clinical development.

What does ABT-102 target?

ABT-102 targets TRPV1, the transient receptor potential vanilloid 1 receptor. It acts as a TRPV1 antagonist, meaning it is designed to block activity at this receptor. TRPV1 is a molecular target of interest in pain and sensory signaling research.

Who makes ABT-102?

ABT-102 is developed by Abbott Laboratories, which trades on the New York Stock Exchange under the ticker ABT. Abbott sponsored the Phase 1 study of ABT-102 conducted in the United States.

What phase is ABT-102 in?

ABT-102 is in Phase 1 clinical development. Its single recorded trial, NCT00854659, was a Phase 1 study that has been completed. ABT-102 is investigational and has not been approved by the FDA for any indication.

What clinical trials is ABT-102 in?

ABT-102 was evaluated in one clinical trial, NCT00854659, titled A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects. The Phase 1 trial enrolled 36 healthy volunteers in the United States, was randomized, double-blind, and placebo-controlled, and is now completed.