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AZD9668

Phase 2

Bronchiectasis | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jan 29, 2013

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

AZD9668 · 10 trials · 5 indications

Phase 2 6Phase 1 4
NCT01054170Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) PatientsChronic Obstructive Pulmonary Disease (COPD)
COMPLETED52 Analytics
NCT01023516Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/FormoterolChronic Obstructive Pulmonary Disease (COPD)
COMPLETED615 Analytics
NCT00949975A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With TiotropiumChronic Obstructive Pulmonary Disease
COMPLETED838 Analytics
NCT00757848A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic FibrosisCystic Fibrosis
COMPLETED56 Analytics
NCT00769119A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With BronchiectasisBronchiectasis
COMPLETED38 Analytics
NCT00703391A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) PatientsChronic Obstructive Pulmonary Disease (COPD)
COMPLETED18 Analytics
PHASE2COMPLETED
Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary Disease (COPD)
NCT0105417052
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PHASE2COMPLETED
Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol
Chronic Obstructive Pulmonary Disease (COPD)
NCT01023516615
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PHASE2COMPLETED
A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
Chronic Obstructive Pulmonary Disease
NCT00949975838
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PHASE2COMPLETED
A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis
Cystic Fibrosis
NCT0075784856
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PHASE2COMPLETED
A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis
Bronchiectasis
NCT0076911938
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PHASE2COMPLETED
A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary Disease (COPD)
NCT0070339118
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Study Endpoints

Primary Endpoints

AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)
Measured after 12 weeks treatment (day 84)

AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.

Baseline Pre-bronchodilator FEV1 (L)
Day 1

Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.

End-value Pre-bronchodilator FEV1 (L)
up to week 12

End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline
Baseline and Values from day 21 to 28

Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

Sputum Percentage Neutrophil Count
Baseline and Values from day 21 to 28

Percentage of neutrophils in white blood cell count.Change from Baseline (mean of 2 baseline visits) to the end of the treatment period (mean of 2 visits at the end of the treatment)

24-hour Sputum Weight
Baseline and day 28

Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.

Forced Expiratory Volume in 1 Second (FEV1)
Baseline and day 28

Forced Expiratory Volume in 1 second (L) as a measure of lung function.Change from Baseline to day 28.

Slow Vital Capacity (SVC)
Baseline and day 28

Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28.

Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)
Baseline and day 28

FEF25-75% (L) as a measure of lung function. Change from Baseline to day 28.

Forced Vital Capacity (FVC)
Baseline and day 28

Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28.

Morning Peak Expiratory Flow (PEF)
Last 7 days on treatment

Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment

Evening Peak Expiratory Flow (PEF)
The last 7 days on treatment

Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment

Bronkotest Diary Card Signs and Symptoms
The last 7 days on treatment

The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.

Cystic Fibrosis Questionnaire (CFQ-R) - Quittner
Baseline and day 28

Cystic Fibrosis Questionnaire Overall Score as a measure of quality of life and disease symptoms. Scores range from 0 to 100, with higher scores indicating better health. The overall score is the sum of 12 subscores. Change from baseline to day 28.

Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline
End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.

Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits

Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline
End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.

Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits

24-hour Sputum Weight(g)
Baseline and day 28

Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28

St George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
Baseline and day 28

SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). Change from baseline to day 28.

Alanine Aminotransferase (ALT)
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

ALT level greater than 3 times the upper limit of normal

Aspartate Aminotransferase (AST)
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

AST level greater than 3 times the upper limit of normal

Creatine Kinase (CK)
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

Change from baseline to Day 14

Total Bilirubin
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

Change from baseline to Day 14

Creatinine
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

Creatinine level greater than the upper limit of normal

Haemoglobin (Hb)
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

Change from baseline to Day 14

Reticulocytes
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

Change from baseline to Day 14

Leucocytes
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

Change from baseline to Day 14

QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method)
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

QTcF interval greater than 450 ms

QTcF
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

QTcF change from baseline greater than 60 ms

FEV1 (Forced Expiratory Volume in the First Second)
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

Change from baseline to Day 14

Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))
Pre-dose on day -1 to day 15 (end of dosing)

AUC(0-12) following 14 days' dosing

Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)
Pre-dose on day -1 to day 15 (end of dosing)

Cmax following 14 days' dosing

Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)
Pre-dose on day -1 to day 15 (end of dosing)

tmax following 14 days' dosing

Terminal Half-life of Drug in Plasma (t1/2)
Pre-dose on day -1 to day 15 (end of dosing)

t1/2 following 14 days' dosing

Renal Clearance of Drug From Plasma (CLR)
Pre-dose on day -1 to day 15 (end of dosing)

CLR following 14 days' dosing

Percentage of radioactive dose recovered in urine and faeces and total balance
Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Concentration of total radioactivity in blood and plasma
Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Plasma concentrations of AZD9668
Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Metabolite profiling and identification in plasma and excreta
Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
PK of AZD9668 (Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR )
Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
The absolute bioavailability and evaluation of pharmacokinetic parameters (AUC, AUC (0-t), Cmax, t½, tmax, and MRT of of a single oral dose and a radiolabelled intravenous microdose of [14C]AZD9668
Multiple Pharmacokinetic blood samples for up to 96 hours following drug administration
Relative bioavailability (Frel): to assess the relative systemic bioavailability after oral administration of the free base of AZD9668 dosed as a suspension compared to the tosylate salt of AZD9668 dosed as a tablet formulation at two dose levels.
Frequent sampling occasions during the study
Relative bioavailability (Frel): to assess the relative systemic bioavailability after oral administration of a tablet variant of AZD9668 compared to AZD9668 tablets.
Frequent sampling occasions during the study

Secondary Endpoints

5th Generation Wall Area Percentage
Measured after 12 weeks treatment (day 84)
Air Trapping Index (ATI) on Expiratory Scans
Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Inspiratory Capacity (IC)
Measured after 12 weeks treatment (day 84)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD9668EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
3ACTIVE_COMPARATORAZD9668 active treatment
4PLACEBO_COMPARATORAZD9668 placebo treatment
AZD9668 active treatmentEXPERIMENTAL -
AZD9668 placebo treatmentPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AZD9668DRUG2 x 30 mg oral tablets twice daily (bid) for 12 weeks
PlaceboDRUG2 x matched placebo to oral tablet twice daily (bid) for 12 weeks
AZD9668 PlaceboDRUG2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks
AZD9668 Placebo equivalentDRUGMatch placebo to 60 mg, oral tablet, twice daily for 28 days
[C14]AZD9668DRUGOral Solution 60 mg Single Dose
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Eligibility Criteria

Age Range50 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Diagnosis of COPD with symptoms over 1 year * FEV1/FVC \< 70% and FEV1 \>= 40 and \< =70 % of predicted post-bronchodilator * Ex-smokers for at least 12 months Exclusion Criteria: * Past history or current evidence of clinically significant heart disease * Current diagnosis ...

Countries:CanadaDenmarkNetherlandsRomaniaUkraineBulgariaCzechiaHungaryPolandSlovakiaUnited StatesAustraliaGermanyJapanPhilippinesRussiaSouth KoreaTaiwanSwedenUnited Kingdom
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Competitive Landscape -Bronchiectasis 8 trials

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN2PHASE2AZD0292
GSK plc Sponsored ADRGSK1PHASE2GSK3862995B
Merck & Co., Inc.MRK1PHASE2Nebulized Ensifentrine
Baxter International Inc.BAX1N/AUndisclosed
Inogen, Inc.INGN1N/AUndisclosed
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Frequently asked questions about AZD9668

What is AZD9668 used for?

AZD9668 is an investigational small molecule being studied for respiratory conditions including chronic obstructive pulmonary disease (COPD), bronchiectasis, and cystic fibrosis. It has been evaluated in clinical trials for these indications, with studies completed in patients with bronchiectasis and COPD.

Who makes AZD9668?

AZD9668 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. AstraZeneca has sponsored clinical trials of AZD9668 in respiratory diseases.

What phase is AZD9668 in?

AZD9668 has completed Phase 2 clinical trials for chronic obstructive pulmonary disease and bronchiectasis. It also completed Phase 1 bioavailability studies. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials has AZD9668 been in?

AZD9668 has been studied in three completed trials. NCT00769119 was a Phase 2 placebo-controlled study in 38 patients with bronchiectasis. NCT00949975 was a Phase 2 dose-ranging study in 838 COPD patients on tiotropium. Two Phase 1 bioavailability studies, NCT01034982 and NCT01035411, enrolled healthy volunteers.

Is AZD9668 the same as any other drug?

AZD9668 is the code name used in clinical trials for this investigational compound. No other brand or alternative names have been publicly associated with this drug in the trial records.