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AZD1981 twice daily for 61/2 days

Phase 1

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Mar 7, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

AZD1981 twice daily for 61/2 days · 1 trial · 1 indication

Phase 1 1
NCT01196689Pharmacokinetics in AdolescentsAsthma
COMPLETED21 Analytics
PHASE1COMPLETED
Pharmacokinetics in Adolescents
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary steady-state outcome variables to assess systemic exposure and oral clearance will be AUCτ, Css,max, Css,trough, and CL/F of AZD1981
0 hours after last dose

Secondary Endpoints

Tolerability and safety assessed by adverse events
During 7 days
Efficacy assessed by Forced Expiratory Volume (FEV) in one second and Asthma Control Questionnaire
Day 1 and 7
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAZD1981 100 mg twice daily for 6 ½ days

Interventions

NameTypeDescription
AZD1981 100 mg twice daily for 61/2 daysDRUG100 mg tablets
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Eligibility Criteria

Age Range12 Years to 17 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * A minimum of 6 months documented history of asthma * Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1 (pre-entry) Exclusion Criteria: * Any clinically significant disea...

Countries:Sweden
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Frequently asked questions about AZD1981 twice daily for 61/2 days

What is AZD1981 used for?

AZD1981 is an investigational small molecule being developed for the treatment of asthma. It is a respiratory therapeutic that has been studied in a Phase 1 clinical trial. The drug is not yet approved and remains in clinical development.

Who makes AZD1981?

AZD1981 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company has conducted clinical research on this investigational asthma treatment.

What phase is AZD1981 in?

AZD1981 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a pharmacokinetic study in adolescents with asthma. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is AZD1981 in?

AZD1981 has been studied in one completed Phase 1 clinical trial, identified as NCT01196689. This trial, titled "Pharmacokinetics in Adolescents," enrolled 21 male participants aged 12 years and older with asthma in Sweden. The study was uncontrolled and not blinded.

How does AZD1981 work?

AZD1981 is a small molecule therapeutic being developed for asthma. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not fully characterized in public data.