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AZD1981 twice daily for 61/2 days

Phase 1

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

AZD1981 twice daily for 61/2 days target and mechanism

Molecular targetPTGDR2
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

AZD1981 twice daily for 61/2 days clinical trials

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 twice daily for 61/2 days?

AZD1981 twice daily for 61/2 days is an investigational small molecule developed by AstraZeneca PLC for asthma. It was studied in a Phase 1 pharmacokinetics trial in adolescents. The dosing description refers to 100 mg taken twice daily over a six and a half day period.

What is AZD1981 100 mg twice daily for 61/2 days used for?

AZD1981 100 mg twice daily for 61/2 days was studied in asthma. The Phase 1 trial enrolled adolescents with asthma in Sweden, not healthy volunteers. AZD1981 twice daily for 61/2 days and AZD1981 100 mg twice daily for 61/2 days are the same investigational regimen.

What does AZD1981 twice daily for 61/2 days target?

AZD1981 twice daily for 61/2 days targets PTGDR2, also known as the DP2 receptor, and acts as an antagonist at that receptor. Antagonism of PTGDR2 is the intended mechanism of this small molecule in asthma.

Who makes AZD1981 twice daily for 61/2 days?

AstraZeneca PLC, which trades under the ticker AZN, is the developer of AZD1981 twice daily for 61/2 days. The compound is an AstraZeneca small molecule studied for respiratory indications including asthma.

What phase is AZD1981 twice daily for 61/2 days in?

AZD1981 twice daily for 61/2 days is in Phase 1 development and is investigational. It has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.

What clinical trials is AZD1981 twice daily for 61/2 days in?

AZD1981 twice daily for 61/2 days was studied in NCT01196689, titled Pharmacokinetics in Adolescents. That Phase 1 trial was completed, enrolled 21 participants with asthma in Sweden, included males aged 12 years and older, and was uncontrolled without randomization or blinding.