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Physostigmine

Phase 1

Insulin Resistance | Small molecule | Metabolic |AstraZeneca PLC|Trials Updated: Mar 13, 2009

Physostigmine development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2008

Physostigmine target and mechanism

Molecular targetACHE
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL94

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Physostigmine clinical trials

Physostigmine · 1 trial · 1 indication

Early Phase 1 1
NCT00689208Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve ActivityInsulin Resistance
COMPLETED12 Analytics
EARLY_PHASE1COMPLETED
Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity
Insulin ResistanceUnlock trial analytics

Study Endpoints

Primary Endpoints

Study the effect of anticholinergic drugs on insulin sensitivity by assessment of glucose infusion rate during hyperinsulinemic euglycemic clamp.
After Insulin bolus, following will be measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).

Secondary Endpoints

Study the effect of cholinergic stimulation on insulin sensitivity by assessment ofglucose infusion rate during hyperinsulinemic euglycemic clamp.
measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).
Study the possible difference in effect of cholinergic (physostigmine) andanticholinergic (atropine) drugs on insulin sensitivity in a lean and abdominal obese subgroup of subjects.
measured; p-glucose (every 5 minutes), blood samples (every 30 minutes), pulse (every 5 minutes the first hour then every 10 minutes), blood pressure will be measured (the same as pulse).
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Interventions

NameTypeDescription
AtropineDRUG10 ug/kg bolus, 4 ug/kg/h infusion
PhysostigmineDRUG0,12ug/kg/min
Placebo SodiumDRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Signed written informed consent * BMI of lean and abdominally obese men and women * weight stable Exclusion Criteria: * Ongoing clinically significant diseases * History of repeated syncope * resting pulse\<50 or systolic blood pressure \<100

Countries:Sweden
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Frequently asked questions about Physostigmine

What is Physostigmine used for in insulin resistance?

Physostigmine is being studied as an investigational small molecule for insulin resistance. AstraZeneca PLC is developing it, and it has completed one early Phase 1 trial in this metabolic indication. It is not an approved treatment for insulin resistance.

What does Physostigmine target?

Physostigmine targets acetylcholinesterase, also known as ACHE. It acts as an inhibitor of this enzyme. This mechanism is being explored in a metabolic context for insulin resistance, though the drug remains investigational.

Who is developing Physostigmine?

AstraZeneca PLC is developing Physostigmine. The company trades under the ticker AZN. The drug is a small molecule being investigated for insulin resistance.

What phase is Physostigmine in?

Physostigmine is in Phase 1 development. One early Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational drug and has not been approved for any indication.

What clinical trials is Physostigmine in?

Physostigmine has been studied in one completed clinical trial, NCT00689208, titled Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity. The early Phase 1 trial enrolled 12 participants in Sweden and included healthy volunteers.