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AZD2066

Phase 2

Pain | Small molecule | Pain |AstraZeneca PLC|Last Updated: Nov 12, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment243

FDA Designations

No designations recorded

Clinical trial landscape

AZD2066 · 8 trials · 5 indications

Phase 2 1Phase 1 7
NCT00857623Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic NeuropathyPain
COMPLETED127 Analytics
PHASE2COMPLETED
Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy
Pain
NCT00857623127
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Study Endpoints

Primary Endpoints

Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment
From baseline to day 28

Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall). Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable.

PK variables
Frequent sampling occasions during
Excretion (rate and extent) of radioactivity in urine and faeces following oral administration of [14C]AZD2066
Until >90% of predicted total radioactivity has been recovered
Pharmacokinetics of total radioactivity in plasma and unchanged AZD2066 in plasma
Sampling at defined timepoints during residential period from pre-dose until 168h post-dose.
Metabolite profile in plasma and excreta
Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.
Manometry
3.45 hours each study period
Safety and tolerability by assessment of vital signs, laboratory variables and ECG
Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 15 and follow up visit 3
Positron emission tomography using the radioligand radioligand [11C]AZ12713580
4 times
AZ2066 pharmacokinetics
several samples within 72 hrs
Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables and ECG
Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 15 and follow up visit 3

Secondary Endpoints

Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.
From baseline to 28 days
Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28
28 days
Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28
28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
AEXPERIMENTALAZD2066
BPLACEBO_COMPARATORPlacebo
CEXPERIMENTALAZD2066
DEXPERIMENTALAZD2066
EPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
AZD2066DRUGCapsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
PlaceboDRUGCapsule, once daily
CaffeineDRUG2 doses, Given as Tablet, 2x50 mg
TolbutamideDRUG2 doses, Given as Tablet, half of 500 mg
Omeprazole Tablet, 20 mgDRUG2 doses, Given as Tablet, 20 mg
Midazolam Tablet, 7.5 mgDRUG2 doses, Given as Tablet, 7.5 mg
radioligand [11C] AZ12713580DRUGsingle dose of iv administered 4 times per subject (3 times together with AZD2066)
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures. * Clinical diagnosis of painful diabetic neuropathy. * non-fertile females Exclusion Criteria: * Other pain that may confound assessment of neuropathic pain. * Ongoing significant peripheral arterial disea...

Countries:United StatesUnited KingdomNetherlandsJapanSweden
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Frequently asked questions about AZD2066

What is AZD2066 used for?

AZD2066 is an investigational small molecule being developed by AstraZeneca for pain, chronic pain, and reflux episodes. It has been studied in healthy volunteers and in a proof-of-principle trial for its effect on transient lower esophageal sphincter relaxations, which are associated with reflux episodes.

How does AZD2066 work?

AZD2066 is a small molecule that targets the metabotropic glutamate receptor 5 (mGluR5). A positron emission tomography (PET) study with [11C]AZ12713580 was conducted to determine central mGluR5 receptor occupancy of AZD2066, indicating that the drug acts on this receptor.

Who is developing AZD2066?

AZD2066 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 1 clinical development.

What phase is AZD2066 in?

AZD2066 is in Phase 1 clinical development. All three completed trials for AZD2066 were Phase 1 studies, and the drug is not yet approved by regulatory authorities. It remains an investigational agent in clinical development.

What clinical trials has AZD2066 been in?

AZD2066 has been studied in three completed Phase 1 trials: NCT00686504, a PET study to determine central mGluR5 receptor occupancy; NCT00690404, a single dose formulation and food effect study; and NCT00766012, a multiple dose study in Japanese subjects. A fourth trial, NCT00813306, assessed its effect on reflux episodes.