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AZD3199 Turbuhaler

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: May 5, 2009

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

Clinical trial landscape

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 being developed by AstraZeneca PLC (AZN). It is currently in Phase 1 clinical development. The drug is administered via a Turbuhaler device and has been studied in healthy volunteers.

What is AZD3199 Turbuhaler used for?

AZD3199 Turbuhaler is being studied in healthy volunteers. The completed Phase 1 trial assessed its safety, tolerability, and pharmacokinetics in healthy Japanese male participants. It is not approved for any disease indication and remains in early clinical development.

Who makes AZD3199 Turbuhaler?

AZD3199 Turbuhaler is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile in healthy subjects.

What phase is AZD3199 Turbuhaler in?

AZD3199 Turbuhaler is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received regulatory approval and is not yet available for clinical use.

What clinical trials is AZD3199 Turbuhaler in?

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

Is AZD3199 Turbuhaler the same as AZD3199?

AZD3199 Turbuhaler refers to the specific formulation of the drug AZD3199 delivered via a Turbuhaler inhalation device. The clinical trial NCT00772759 evaluated this formulation in healthy volunteers to assess its safety, tolerability, and pharmacokinetics.