Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD5069 · 11 trials · 17 indications
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Adverse event (AE) data, both serious and non-serious. An AE is the development of an undesirable medical condition (eg, nausea, chest pain, tachycardia, laboratory findings) or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
Physical examination includes assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, musculo-skeletal (including spine and extremities), cardiovascular, lungs and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.
ECGs were recorded in the supine position after the patient has rested for 10 minutes. Heart rate, QRS duration, PR, RR and QT intervals were recorded. Overall evaluation of the ECG is classified as normal, abnormal or borderline. Only participants with ECG at baseline classified as normal are reported (ie, only changes from normal to abnormal).
The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.
The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.
The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.
The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.
The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.
High Transaminase Values are defined as a measurment of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than or equal to 3 times the upper limit of normal (ALT ULN = 36 IU/L, AST ULN = 33 IU/L).
The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.
Change from baseline reflects the Week 4 value minus the baseline value. Baseline value is Day-14 measurement. For semi-quantitative scores, 1= few number of Neutrophils, 2= moderate number of Neutrophils, 3= abundant of Neutrophils. For this end point the reduction in mean of semi-quantitative (arbitrary) scores indicates better result, i.e. lower numbers of Neutrophils. The scores given for the biopsies taken at screening and end of treatment is the mean global semi-quantitative scores for the three compartments intraepithelial, subepithelial and submucosal.
Change from Baseline reflects the Day 8, Day22 and Day29 minus the baseline value.
Change from Baseline reflects the Day 2, Day 8, Day 15, Day 22, Day29 and Day 34 minus the baseline value
(AUC(0-t)) area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, (Cmax) observed maximum plasma concentration, (λz) terminal rate constant, (t½λz) terminal half-life, (tmax) time to reach maximum plasma concentration (tmax), (CL/F) apparent oral clearance (AZD5069 only), (Vz/F) apparent volume of distribution.
To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of \[14C\] radioactivity in plasma and whole blood and the resulting area under the concentration-time curve from zero extrapolated to infinity (AUC), to the last measurable concentration (AUC(0 t)).
| Arm | Type | Description |
|---|---|---|
| AZD5069 5 mg | EXPERIMENTAL | AZD5069 oral capsules self-administered twice daily |
| AZD5069 15 mg | EXPERIMENTAL | AZD5069 oral capsules self-administered twice daily |
| AZD5069 45 mg | EXPERIMENTAL | AZD5069 oral capsules self-administered twice daily |
| Placebo | PLACEBO_COMPARATOR | Placebo oral capsules self-administered twice daily |
| 1 | EXPERIMENTAL | Treatment arm AZD5069 |
| 2 | PLACEBO_COMPARATOR | Placebo dose. |
| 3 | EXPERIMENTAL | Treatment arm AZD5069 80mg |
| First AZD5069, then Ketoconazole + AZD5069 | EXPERIMENTAL | AZD5069 in first period (on 1 day) and in second period (after wash out) ketoconazole alone (on 2 days) then ketoconazole + AZD5069 (on 1 day), then again ketoconazole alone (on 2 days) |
| Active | EXPERIMENTAL | AZD5069 oral solution |
| Name | Type | Description |
|---|---|---|
| AZD5069 | DRUG | AZD5069 oral capsules self-administered twice daily. |
| Placebo | DRUG | Placebo oral capsules self-administered twice daily. |
| AZD5069 50mg | DRUG | Oral dose bid |
| AZD5069 80mg | DRUG | Oral dose bid |
| Ketoconazole | DRUG | Ketoconazole 400 mg (2x200 mg tablets) |
| 100 mg (50 mg x 2) AZD5069 | DRUG | Twice daily for 7 days |
| 100 mg Placebo | DRUG | Twice daily for 7 days |
| [14C] AZD5069 | DRUG | Single 120 mg oral dose administered on Day 1 |
Inclusion Criteria: * Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method plus a condom by their male partner. * Diagnosis of asthma for at least 12 months (GINA 2011) * Uncontrolled persistent asthma, despite treatment with medi...
AZD5069 is an investigational small molecule being studied for respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), and bronchiectasis. It has been evaluated in clinical trials for uncontrolled persistent asthma and bronchiectasis. The drug is not approved and remains in clinical development.
AZD5069 targets the chemokine receptor 2 (CXCR2), a receptor involved in neutrophil recruitment and inflammation. By antagonizing CXCR2, the drug aims to reduce neutrophil-driven inflammation in respiratory diseases. This mechanism is relevant to conditions like asthma and bronchiectasis where neutrophilic inflammation plays a role.
AZD5069 is developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca has sponsored clinical trials of AZD5069 in respiratory indications, including asthma and bronchiectasis.
AZD5069 has completed Phase 2 clinical trials. It has been studied in a Phase 2 trial for uncontrolled persistent asthma and a Phase 2 trial for bronchiectasis. The drug is investigational and has not received FDA approval. No active trials are currently listed for AZD5069.
AZD5069 has completed four clinical trials. These include NCT00953888, a Phase 1 healthy volunteer study; NCT01255592, a Phase 2 bronchiectasis trial; NCT01704495, a Phase 2 asthma trial; and NCT01890148, a Phase 1 asthma study. All trials are completed, with no active trials ongoing.
AZD5069 is the primary name for this investigational drug. No alternative names have been reported. It is sometimes referred to as AZD 5069 in clinical trial documents, but this is a formatting variation rather than a distinct name.