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AZD3199 Turbuhaler

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: May 5, 2009

AZD3199 Turbuhaler development status

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

AZD3199 Turbuhaler target and mechanism

Molecular targetADRB2
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

AZD3199 Turbuhaler clinical trials

AZD3199 Turbuhaler · 1 trial · 1 indication

Phase 1 1
NCT00772759Assess Safety, Tolerability and PK of AZD3199 in JapaneseHealthy
COMPLETED27 Analytics
PHASE1COMPLETED
Assess Safety, Tolerability and PK of AZD3199 in Japanese
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety/Tolerability - adverse events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP), pulse rate, lung function parameters, body temperature and laboratory variables (clinical chemistry, haematology and urinalysis)
During the study

Secondary Endpoints

Pharmacokinetic Parameters derived from plasma concentration and optionally urinary excretion of AZD3199.
During residential period
Pharmacodynamic Potassium and lactate concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure, and forced expiratory volume in one second (FEV1).
During residential period
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDry powder for oral inhalation
2PLACEBO_COMPARATORDry powder for oral inhalation

Interventions

NameTypeDescription
AZD3199 Turbuhaler®DRUG240, 720 and 2160 μ g, single and multiple (o.d. for 12 days)
Placebo Turbuhaler®DRUGsingle and multiple (o.d. for 12 days)
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Be healthy Japanese volunteers, both of the volunteer's parents, and all grandparents must be Japanese. The volunteer must have been born in Japan, have a valid Japanese passport and must not have lived outside Japan for for more than 5 years. * BMI 18 - 27, Weight 50 - 85 kg ...

Countries:United Kingdom
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Frequently asked questions about AZD3199 Turbuhaler

What is AZD3199 Turbuhaler?

AZD3199 Turbuhaler is an investigational small molecule drug developed by AstraZeneca PLC (ticker AZN). It is delivered through a Turbuhaler device and has been studied in a Phase 1 clinical trial in healthy volunteers. Its therapeutic indication has not been disclosed.

What does AZD3199 Turbuhaler target?

AZD3199 Turbuhaler targets ADRB2, the beta-2 adrenergic receptor, and acts as an agonist at that receptor. This target class places it among beta-2 adrenergic receptor agonists, a group commonly explored for airway-related conditions.

Who makes AZD3199 Turbuhaler?

AZD3199 Turbuhaler is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program for this investigational compound.

What phase is AZD3199 Turbuhaler in?

AZD3199 Turbuhaler is in Phase 1 development. It is an investigational drug and is not approved; the only recorded trial is a completed Phase 1 study. No active trials are currently listed for this asset.

What clinical trials is AZD3199 Turbuhaler in?

AZD3199 Turbuhaler has been evaluated in one clinical trial, NCT00772759, titled "Assess Safety, Tolerability and PK of AZD3199 in Japanese." That Phase 1 study was completed, enrolled 27 healthy male participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United Kingdom.

Is AZD3199 Turbuhaler the same as AZD3199 Turbuhaler®?

Yes. AZD3199 Turbuhaler and AZD3199 Turbuhaler® refer to the same investigational drug from AstraZeneca. The registered trademark symbol is simply a naming variant, so searches using either form point to the same compound and the same clinical program.