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opioid receptor kappa antagonist

Phase 1

Alcohol Dependence | Small molecule | Psychiatry |Eli Lilly and Company|Last Updated: May 9, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

opioid receptor kappa antagonist · 1 trial · 1 indication

Phase 1 1
NCT01232439A Study of Brain Receptor Occupancy in Healthy SubjectsAlcohol Dependence
COMPLETED13 Analytics
PHASE1COMPLETED
A Study of Brain Receptor Occupancy in Healthy Subjects
Alcohol DependenceUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)
Baseline, after single dose of study drug

Secondary Endpoints

Pharmacokinetics, area under the curve (AUC)
Days 1 and 2
Number of participants with clinically significant effects
Baseline to study completion
Pharmacokinetics, concentration maximum (Cmax)
Days 1 and 2
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
opioid receptor kappa antagonistEXPERIMENTAL -

Interventions

NameTypeDescription
opioid receptor kappa antagonistDRUGStarting dose of 2 mg, administered orally, once. The potential dose range for this study is 0.2 mg to 30 mg
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female * Have clinical laboratory tests within normal reference ranges * Have arterial and venous access sufficient to allow blood sampling Exclusion Criteria: * Currently enrolled in, or discontinued within the last 30 days from a clinical trial * History of...

Countries:United States
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Frequently asked questions about opioid receptor kappa antagonist

What is opioid receptor kappa antagonist used for?

Opioid receptor kappa antagonist is an investigational small molecule being studied for the treatment of alcohol dependence. It is in Phase 1 clinical development and has not been approved by the FDA. The drug is intended to act on the kappa opioid receptor, though its exact mechanism in alcohol dependence is still under investigation.

What does opioid receptor kappa antagonist target?

Opioid receptor kappa antagonist targets the kappa opioid receptor. By blocking this receptor, the drug may modulate brain pathways involved in alcohol dependence. However, the specific therapeutic effects and clinical benefits are still being evaluated in early-stage clinical trials.

Who makes opioid receptor kappa antagonist?

Opioid receptor kappa antagonist is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is currently in Phase 1 clinical development for alcohol dependence.

What phase is opioid receptor kappa antagonist in?

Opioid receptor kappa antagonist is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for alcohol dependence.

What clinical trials is opioid receptor kappa antagonist in?

Opioid receptor kappa antagonist has one completed Phase 1 clinical trial registered as NCT01232439, titled "A Study of Brain Receptor Occupancy in Healthy Subjects." The trial enrolled 13 participants in the United States and studied the drug's receptor occupancy in healthy volunteers, including those with alcohol dependence.