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Phase IIb formulation

Phase 1

Uncontrolled and Persistent Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jun 25, 2015

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Phase IIb formulation · 1 trial · 1 indication

Phase 1 1
NCT01989520Study to Investigate Relative Bioavailability of up to Five Different Formulations of AZD5069Uncontrolled and Persistent Asthma
COMPLETED36 Analytics
PHASE1COMPLETED
Study to Investigate Relative Bioavailability of up to Five Different Formulations of AZD5069
Uncontrolled and Persistent Asthma
NCT0198952036
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Study Endpoints

Primary Endpoints

Description of pharmacokinetics of AZD5069 and its metabolite in terms of area under plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration and extrapolated to infinity (AUC(0-last) and AUC)
Samples taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose

Curve taken during each of the 5 treatments

Description of pharmacokinetics of AZD5069 and its metabolite in terms of observed maximum plasma concentration (Cmax), plasma concentration measured at 12 hours (C12h), Cmax/C12h ratio, Cmax/AUC ratio, terminal rate constant (λz)
Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose

Curve taken during each of the 5 treatments

Description of pharmacokinetics of AZD5069 and its metabolite in terms of terminal half-life (t½λz), time to reach maximum plasma concentration (tmax)
Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose

Curve taken during each of the 5 treatments

Description of pharmacokinetics of AZD5069 and its metabolite in terms of apparent systemic clearance (CL/F) (AZD5069 only), and apparent volume of distribution (Vz/F) (AZD5069 only)
Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose

Curve taken during each of the 5 treatments

Secondary Endpoints

Description of effect on neutrophils in terms of circulating neutrophil numbers reported as absolute circulating neutrophil counts (ANC). The minimum absolute neutrophil count (ANCmin) and the time to ANCmin (ANCtmin)
Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose
Description of effect on neutrophils in terms of mean of ANC values from predose to 24 hours postdose (ANCmean), the minimum of the ANC ratio values (ANCmin,ratio)
Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose
Description of effect on neutrophils in terms of the mean of ANC ratio values calculated baseline to 24 hours post dose (ANCmean,ratio)
Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTALPhase IIb formulation
Treatment BEXPERIMENTALPutative phase III formulation
Treatment CEXPERIMENTALSlow dissolution variant 1
Treatment DEXPERIMENTALSlow dissolution variant 2
Treatment EEXPERIMENTALOptional treatment that may use one of 3 45 mg (intermediate dissolution variant) of AZD5069

Interventions

NameTypeDescription
Phase IIb formulationDRUGSingle oral dose 45mg AZD5069
Putative phase III formulationDRUGSingle oral dose 45mg AZD5069
Slow dissolution variant 1DRUGSingle oral dose 45mg AZD5069
Slow dissolution variant 2DRUGSingle oral dose 45mg AZD 5069
Test treatment EDRUGTablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male and/or female volunteers aged 18 to 50 years (inclusive). 2. Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening. 3. Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum (min) w...

Countries:United Kingdom
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Frequently asked questions about Phase IIb formulation

What is AZD5069 used for?

AZD5069 is an investigational small molecule being developed for the treatment of uncontrolled and persistent asthma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does AZD5069 target?

AZD5069 is a small molecule designed to target a specific pathway involved in asthma. The exact molecular target has not been disclosed in available clinical trial information.

Who is developing AZD5069?

AZD5069 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN.

What phase is AZD5069 in?

AZD5069 is currently in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval for any indication.

What clinical trials is AZD5069 in?

AZD5069 has one completed Phase 1 clinical trial, identified as NCT01989520. This study investigated the relative bioavailability of up to five different formulations of AZD5069 in healthy volunteers.

Is AZD5069 the same as other asthma treatments?

AZD5069 is a distinct investigational compound developed by AstraZeneca. It is not known to be the same as any other marketed asthma medication.