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AZD1981, current small-particle

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 7, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials4
Total Enrollment81

FDA Designations

No designations recorded

Clinical trial landscape

AZD1981, current small-particle · 4 trials · 3 indications

Phase 1 4
NCT01311635A Bioavailability Study Comparing 3 Different AZD1981 TabletsHealthy
COMPLETED16 Analytics
NCT01058447Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male VolunteersHealthy
COMPLETED4 Analytics
NCT00918398AZD1981 Bioavailability Study of Intravenous (IV) and Oral FormulationsHealthy
COMPLETED14 Analytics
NCT00698282Single and Multiple Ascending Doses of AZD1981 in JapanHealthy
COMPLETED47 Analytics
PHASE1COMPLETED
A Bioavailability Study Comparing 3 Different AZD1981 Tablets
HealthyUnlock trial analytics
PHASE1COMPLETED
Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers
HealthyUnlock trial analytics
PHASE1COMPLETED
AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations
HealthyUnlock trial analytics
PHASE1COMPLETED
Single and Multiple Ascending Doses of AZD1981 in Japan
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981
Pharmacokinetic (PK) sampling continuously for 60 h after each single dose, ie day 1-3 for each period.
Pharmacokinetic variables and Radioactivity
Frequent sampling occasions during study days
PK samples for AZD1981 from both blood and urine
Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose.
Adverse events
All the time
Plasma drug concentration
Every hour

Secondary Endpoints

To evaluate basic systemic PK parameters as follows:
PK sampling continuously for 60 h after each single dose, ie day 1-3 for each period
To evaluate the safety and tolerability of AZD1981 by assessment of adverse events, laboratory safety parameters, vital signs, ECG, physical examination and weight
Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
Frequent sampling occasions during study days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTAL -
Treatment BEXPERIMENTAL -
Treatment CEXPERIMENTAL -
Treatment DEXPERIMENTAL -
1EXPERIMENTAL -
2EXPERIMENTALAZD1981, 514 mg oral solution
3EXPERIMENTALAZD1981, 500 mg oral tablet A
4EXPERIMENTALAZD1981, 500 mg oral tablet B

Interventions

NameTypeDescription
AZD1981, current small-particle tabletDRUG3x100 mg per oral, single dose in fasted state
AZD1981, new small-particle tabletDRUG3x100 mg per oral, single dose
AZD1981, new large-particle tableDRUG3x100 mg per oral, single dose in fasted state
AZD1981DRUGOral tablet, 250 mg, single dose
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive * Have a body mass index between 19-30 kg/m2 and weigh at least 50 kg and no more than 100 kg, inclusive * Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to...

Countries:SwedenUnited Kingdom
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Frequently asked questions about AZD1981, current small-particle

What is AZD1981 used for?

AZD1981 is an investigational small molecule being studied for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD). It has also been evaluated in healthy volunteers for pharmacokinetic and drug interaction studies, including its effects on oral contraceptives and the QT interval.

Who makes AZD1981?

AZD1981 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company has conducted clinical trials to assess the drug's efficacy and safety in patients with moderate to severe COPD.

What phase is AZD1981 in?

AZD1981 is in Phase 2 clinical development for moderate to severe COPD. It has completed a Phase 2 efficacy and safety study, along with several Phase 1 trials in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is AZD1981 in?

AZD1981 has completed four clinical trials. The main efficacy study, NCT00690482, was a Phase 2 trial in patients with moderate to severe COPD. Other completed trials include NCT00859352, a Phase 1 study in healthy male volunteers, NCT01110525, a drug interaction study with oral contraceptives, and NCT01265641, a QT interval study.

Is AZD1981 the same as any other drug?

AZD1981 is the code name for this investigational compound developed by AstraZeneca. No alternative brand names or other designations have been disclosed in the clinical trial records. The drug is identified solely by its development code AZD1981 in all completed studies.

How does AZD1981 work?

AZD1981 is a small molecule being investigated for respiratory conditions. The specific molecular target or mechanism of action has not been disclosed in the available clinical trial information. The drug's efficacy in COPD was assessed in a placebo-controlled Phase 2 study, but its biological pathway remains unspecified.