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AZD6280

Phase 1

Anxiety | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Dec 10, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

AZD6280 · 4 trials · 3 indications

Phase 1 4
NCT00824057Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)Healthy
COMPLETED24 Analytics
NCT00750802A Sedation/Cognition/EEG Study Using AZD6280 and ComparatorHealthy Volunteer
COMPLETED17 Analytics
NCT00681317AZD6280 Multiple Ascending Dose StudyHealthy Volunteer
COMPLETED48 Analytics
NCT00681746Positron Emission Tomography (PET) Study With (11C) Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280Anxiety
COMPLETED8 Analytics
PHASE1COMPLETED
Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)
HealthyUnlock trial analytics
PHASE1COMPLETED
A Sedation/Cognition/EEG Study Using AZD6280 and Comparator
Healthy VolunteerUnlock trial analytics
PHASE1COMPLETED
AZD6280 Multiple Ascending Dose Study
Healthy VolunteerUnlock trial analytics
PHASE1COMPLETED
Positron Emission Tomography (PET) Study With (11C) Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280
AnxietyUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the effects of repeated doses of AZD6280 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).
Blood samples will be taken throughout the 19-day inpatient period of the study.
Evaluation of the pharmacodynamic effects of AZD6280 by central nervous system function tests
Test batteries will be performed at specified times both before and following study drug administration
To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs
Assessments are made at each visit, at least daily, during the study.
Positron emission tomography using the radioligand (11C) flumazenil
4 times per subject

Secondary Endpoints

To evaluate the safety and tolerability of repeated doses of AZD6280 in combination with midazolam and caffeine.
Observations taken post dosing.
Evaluation of the pharmacodynamic effects of AZD6280
Test batteries will be performed before and following study drug administration.
To evaluate the pharmacokinetics of AZD6280
Blood samples will be taken throughout the 19-day inpatient period of the study.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3ACTIVE_COMPARATOR -
4PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AZD6280DRUGoral
MidazolamDRUGoral
CaffeineDRUGoral
LorazepamDRUG2mg tablet, oral single-dose
PlaceboDRUG -
(11C) flumazenilDRUGSingle dose of intravenous solution. 4 times for 2 subjects in Panel 1. 2 times for the remaining 6 subjects. (once together with AZD6280)
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects aged 18 to 45 years (inclusive) on Day 1. Exclusion Criteria: * Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor. * Enrollment in another c...

Countries:United KingdomNetherlandsUnited StatesSweden
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Frequently asked questions about AZD6280

What is AZD6280 used for?

AZD6280 is an investigational small molecule being developed by AstraZeneca for psychiatry, specifically studied in healthy volunteers and in anxiety. It is in Phase 1 clinical development, meaning it is still in early-stage testing and not yet approved for any use.

Who makes AZD6280?

AZD6280 is being developed by AstraZeneca PLC, a multinational pharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials, and AstraZeneca is the sponsor of the studies listed for this compound.

What phase is AZD6280 in?

AZD6280 is in Phase 1 clinical development. All four clinical trials for AZD6280 are Phase 1 studies and have been completed. The drug is investigational, meaning it has not been approved by regulatory authorities and is still undergoing early-stage testing in humans.

What clinical trials is AZD6280 in?

AZD6280 has been studied in four completed Phase 1 trials: NCT00681317, a multiple ascending dose study in healthy volunteers; NCT00681746, a PET study measuring GABAA receptor occupancy in anxiety; NCT00750802, a sedation/cognition/EEG study; and NCT00824057, a drug interaction study with midazolam and caffeine.

How does AZD6280 work?

AZD6280 is a small molecule that targets the GABAA receptor, as indicated by a PET study using (11C) flumazenil to determine central GABAA receptor occupancy. By binding to this receptor, it may modulate inhibitory neurotransmission in the brain, which is relevant to its study in anxiety.

Is AZD6280 the same as another drug?

AZD6280 is the only name provided for this compound in the clinical trial data. There are no alternative names listed for AZD6280 in the available information, so it is not known to be the same as any other marketed or investigational drug under a different name.