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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002951-21 | EudraCT Number |
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The purpose of the study is to assess the safety and tolerability of AZD6793 suspension following oral administration of Single Ascending Dose (SAD) [Part 1] and Multiple Ascending Dose (MAD) [Part 2] in healthy participants.
Additionally, the study will include Part 3 (bioavailability and food effect cohort) to assess the relative oral bioavailability between test formulation and oral suspension (reference formulation) as well as the effect of a high fat high calorie (HFHC) meal on the PK of AZD6793 test formulation, in comparison to fasting conditions, after a single oral dose of AZD6793 in healthy participants.
Part 4 of the study (Chronic Obstructive Pulmonary Disease [COPD] cohort) is intended to evaluate AZD6793 safety, tolerability, and PK profile for the first time in participants with moderate to severe COPD.
Part 1 (SAD), Part 2 (MAD) and Part 3 (Bioavailability and food effect cohort) have been completed. Although it was planned that 5 cohorts would be included in Part 1, only 4 cohorts (32 participants) were included. Part 3 of the study was concluded with 13 healthy participants.
Parts 1, 2, and 3 were conducted in a single center and Part 4 is conducted in 2 centers.
Part 1 of the study will comprise:
Part 2 of the study will comprise:
Part 3 of the study will comprise:
Part 4 of the study will comprise:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (SAD): Cohort 1 | Experimental | 6 Healthy participants will receive a single oral dose A of AZD6793 and 2 healthy participants will receive placebo |
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| Part 1 (SAD): Cohort 2 | Experimental | 6 Healthy participants will receive a single oral dose B of AZD6793 and 2 healthy participants will receive placebo |
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| Part 1 (SAD): Cohort 3 | Experimental | 6 Healthy participants will receive a single oral dose C of AZD6793 and 2 healthy participants will receive placebo |
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| Part 1 (SAD): Cohort 4 | Experimental | 6 Healthy participants will receive a single oral dose D of AZD6793 and 2 healthy participants will receive placebo |
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| Part 1 (SAD): Cohort 5 | Experimental | 6 Healthy participants will receive a single oral dose E of AZD6793 and 2 healthy participants will receive placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6793 | Drug | AZD6793 will be administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (SAD): Number of participants with adverse events | Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants. | From screening up to Follow up visit (Day 6±1) |
| Part 2 (MAD): Number of participants with adverse events | Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants. | From screening up to Follow up visit (Day 14±1) |
| Part 1 (SAD): Number of participants with abnormal findings in vital signs (supine Blood Pressure (BP), pulse, respiratory rate, peripheral oxygen saturation (SpO2) and oral body temperature) | Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants. | From screening, Treatment Day 1 to Day 4 up to Follow up visit (Day 6±1) |
| Part 2 (MAD): Number of participants with abnormal findings in vital signs (supine Blood Pressure (BP), pulse, respiratory rate, peripheral oxygen saturation (SpO2) and oral body temperature) | Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants. | From screening, Treatment Day -1 to Day 10 up to Follow up visit (Day 14±1) |
| Part 1 (SAD): Number of participants with abnormal findings in 12 Lead electrocardiogram (ECG) | Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants. | From screening, Treatment Day -1 to Day 4 up to Follow up visit (Day 6±1) |
| Part 2 (MAD): Number of participants with abnormal findings in 12 Lead electrocardiogram (ECG) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (SAD): Maximum observed plasma (peak) drug concentration (Cmax) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 1 (SAD): Time to reach peak or maximum observed concentration or response following drug administration (tmax) |
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Main Inclusion Criteria:
Parts 1,2 and 3:
Part 4:
Male and/or female participants, who have moderate to severe COPD, and aged 40 through 80 years inclusive.
BMI between 18 to 44.9 kg/m2 at Screening
Documented history of COPD with a post-bronchodilator FEV1/FVC <0.70 and a post-bronchodilator FEV1 ≥ 30% and < 80% predicted at Screening
Documented stable inhaled treatment regimen of dual therapy or triple therapy for ≥ 3 months prior to Screening.
Clinically stable and free from an Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in the opinion of the Investigator for at least 35 days prior to Day 1
Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of :
Male participants and their female partners of childbearing potential must be willing to use highly effective contraception measures and must refrain from donating sperm or fathering a child from first day of dosing until 3 months after last IMP dose.
Main Exclusion Criteria:
Parts 1,2 and 3:
Part 4:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Harrow | HA1 3UJ | United Kingdom | |||
| Research Site |
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| Label | URL |
|---|---|
| Redacted CSR Synopsis | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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The study consists of 4 parts:
Part 1 (SAD): In this part, healthy participants will be randomised in 5 cohorts (may add up to 3 additional cohorts) to receive AZD6793 with 8 evaluable participants in each cohort.
Part 2 (MAD): In this part, healthy participants will be randomised in 3 cohorts (may add up to 3 additional cohorts) to receive AZD6793 with 8 evaluable participants in each cohort.
Part 3 (Bioavailability and Food Effect Cohort): In this cohort, 15 healthy participants will be randomised to receive AZD6793 with 12 evaluable participants.
Part 4 (COPD Cohort): 15 COPD participants will be randomised in the ratio 2:1 to receive AZD6793 or placebo.
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| Part 2 (MAD): Cohort 1 | Experimental | 6 Healthy participants will receive dose W of AZD6793 and 2 healthy participants will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7 |
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| Part 2 (MAD): Cohort 2 | Experimental | 6 Healthy participants will receive dose X of AZD6793 and 2 healthy participants will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7 |
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| Part 2 (MAD): Cohort 3 | Experimental | 6 Healthy participants will receive dose Y of AZD6793 and 2 healthy participants will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7 |
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| Part 2 (MAD) : Cohort 4 | Experimental | 6 Healthy participants will receive dose Z of AZD6793 and 2 healthy participants will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7 |
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| Part 3: Treatment sequence 1 | Experimental | Participants will receive a single oral dose of test formulation AZD6793 in fasted state, test formulation AZD6793 in fed state following reference formulation AZD6793 in fasted state once on Day 1 of each treatment period. |
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| Part 3: Treatment sequence 2 | Experimental | Participants will receive a single oral dose of test formulation AZD6793 in fed state, reference formulation AZD6793 in fasted state following test formulation AZD6793 in fasted state once on Day 1 of each treatment period. |
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| Part 3: Treatment sequence 3 | Experimental | Participants will receive a single oral dose of reference formulation AZD6793 in fasted state, test formulation AZD6793 in fasted state following test formulation AZD6793 in fed state once on Day 1 of each treatment period. |
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| Part 4 (COPD): Cohort 1 | Experimental | 10 participants with COPD will receive AZD6793 once daily and 5 participants with COPD will receive placebo |
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| Placebo | Drug | Placebo will be administered orally |
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Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
| From screening, Treatment Day -1 to Day 10 up to Follow up visit (Day 14±1) |
| Part 1 (SAD): Number of participants with abnormal findings in 12 Lead Digital electrocardiogram (dECG) | Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 2 (MAD): Number of participants with abnormal findings in 12 Lead Digital electrocardiogram (dECG) | Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 3, Day 5, Day 8 to Day 10 |
| Part 1 (SAD): Number of participants with abnormal findings in Telemetry | Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants. | Day -1 to Day 3 |
| Part 2 (MAD): Number of participants with abnormal findings in Telemetry | Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants. | Day -1 to Day 2 and Day 8 to Day 10 |
| Part 1 (SAD): Number of participants with abnormal findings in Physical examinations | Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants. | From screening, Treatment Day -1 to 4 and follow up visit |
| Part 2 (MAD): Number of participants with abnormal findings in Physical examinations | Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants. | From screening, Treatment Day -1 to 10 and follow up visit |
| Part 1 (SAD): Number of participants with abnormal findings in Laboratory assessments (haematology, serum clinical chemistry, and urinalysis) | Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants. | From screening, Treatment Day -1, Day 2, Day 4 and Follow up visit (Day 6±1) |
| Part 2 (MAD): Number of participants with abnormal findings in Laboratory assessments (haematology, serum clinical chemistry, and urinalysis) | Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants. | From screening, Treatment Day -1 to Day 10 up to Follow up visit (Day 14±1) |
| Part 3 (Bioavailability): Maximum observed plasma (peak) drug concentration [Cmax] | Evaluating the relative oral bioavailability between the test formulation and the reference formulation after a single oral dose of AZD6793 in healthy participants. | Day 1 to Day 3 |
| Part 3 (Bioavailability): Area under plasma concentration-time curve from zero to infinity [AUCinf] | Evaluating the relative oral bioavailability between the test formulation and the reference formulation after a single oral dose of AZD6793 in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect): Cmax of AZD6793 | Investigating the effect of a high fat high calorie (HFHC) meal compared to fasting conditions, on the PK of AZD6793 after a single oral dose in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect): AUCinf of AZD6793 | Investigating the effect of a high fat high calorie (HFHC) meal compared to fasting conditions, on the PK of AZD6793 after a single oral dose in healthy participants. | Day 1 to Day 3 |
| Part 4 (COPD): Number of participants with adverse events | Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants. | From screening up to Follow up visit (Day 34±2) |
| Part 4 (COPD): Number of participants with abnormal findings in vital signs (supine Blood Pressure (BP), pulse, respiratory rate, peripheral oxygen saturation (SpO2) and oral body temperature) | Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants. | From screening up to Follow up visit (Day 34±2) |
| Part 4 (COPD): Number of participants with abnormal findings in 12 Lead electrocardiogram (ECG) | Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants. | From screening up to Follow up visit (Day 34±2) |
| Part 4 (COPD): Number of participants with abnormal findings in Physical examinations | Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants. | From screening, Treatment Day -1, 1, 14, 28 and follow up visit (34±2) |
| Part 4 (COPD): Number of participants with abnormal findings in Laboratory assessments (haematology, clinical chemistry, coagulation tests, and urinalysis) | Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants. | From screening up to Follow up visit (Day 34±2) |
Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. |
| Day 1 to Day 3 |
| Part 1 (SAD): Terminal rate constant, estimated by log linear least squares regression of the terminal part of the concentration time curve (λz) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 1 (SAD): Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve ( t½λz) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 1 (SAD): Partial area under the plasma concentration time curve from time 0 to time 12 (AUC(0-12)) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 1 (SAD): Partial area under the plasma concentration time curve from time 0 to time 24 (AUC(0-24)) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 1 (SAD): Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 1 (SAD): Area under plasma concentration time curve from zero to infinity (AUCinf) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 1 (SAD): Apparent total body clearance of drug from plasma after extravascular administration (CL/F) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 1 (SAD): Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase) (Vz/F) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 1 (SAD): Area under the plasma concentration time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (Dose normalised AUClast) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 1 (SAD): Area under the plasma concentration time curve from time zero extrapolated to infinity divided by the dose administered (Dose normalised AUCinf) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 1 (SAD): Maximum observed plasma (peak) drug concentration divided by the dose administered (Dose normalised Cmax). | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 3 |
| Part 2 (MAD): Maximum observed plasma (peak) drug concentration (Cmax) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Concentration at the end of the dosing interval (Ctrough) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Temporal change parameter (TCP) assessed in urine | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy participants. | Day 1 and Day 8 |
| Part 2 (MAD): Time to reach peak or maximum observed concentration or response following drug administration (tmax) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Terminal rate constant, estimated by log linear least squares regression of the terminal part of the concentration time curve (λz) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve ( t½λz) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Partial area under the plasma concentration time curve from time 0 to time 24 (AUC(0-24)) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Area under plasma concentration time curve from zero to infinity (AUCinf) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Area under plasma concentration time curve in the dosing interval t (AUCt) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Apparent total body clearance of drug from plasma after extravascular administration (CL/F) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase) (Vz/F) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Area under the plasma concentration time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (Dose normalised AUClast) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Area under the plasma concentration-time curve from time zero to the dosing interval t concentration divided by the dose administered (Dose normalised AUCt) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Maximum observed plasma (peak) drug concentration divided by the dose administered (Dose normalised Cmax) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Ratio of the area under the curve (Rac AUC) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Accumulation ratio based on Cmax (Rac Cmax) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 to Day 10 |
| Part 2 (MAD): Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1 t2)] | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 and Day 8 |
| Part 2 (MAD): Cumulative amount of unchanged drug excreted into urine (Aeinf) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 and Day 8 |
| Part 2 (MAD): Renal clearance of drug from plasma (CLR) assessed in urine | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy participants. | Day 1 and Day 8 |
| Part 3 (Bioavailability): Cmax of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy participants | Day 1 to Day 3 |
| Part 3 (Bioavailability): tmax of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy participants | Day 1 to Day 3 |
| Part 3 (Bioavailability): λz of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy participants | Day 1 to Day 3 |
| Part 3 (Bioavailability): t½λz of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy participants | Day 1 to Day 3 |
| Part 3 (Bioavailability): AUC(0-12) of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy participants | Day 1 to Day 3 |
| Part 3 (Bioavailability): AUC(0-24) of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy participants | Day 1 to Day 3 |
| Part 3 (Bioavailability): AUClast of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy participants | Day 1 to Day 3 |
| Part 3 (Bioavailability): AUCinf of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy participants | Day 1 to Day 3 |
| Part 3 (Bioavailability): CL/F of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy participants | Day 1 to Day 3 |
| Part 3 (Bioavailability): Vz/F of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy participants | Day 1 to Day 3 |
| Part 3 (Bioavailability) :Relative bioavailability calculated as test AUC/reference AUC [Frel AUC] | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy participants | Day 1 to Day 3 |
| Part 3 (Bioavailability): Relative bioavailability calculated as test Cmax/reference Cmax [Frel Cmax] | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy participants | Day 1 to Day 3 |
| Part 3 (Food effect): Cmax of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 test formulation under fasted and fed (after intake of a HFHC meal) conditions in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect): tmax of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 test formulation under fasted and fed (after intake of a HFHC meal) conditions in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect): λz of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 test formulation under fasted and fed (after intake of a HFHC meal) conditions in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect): t½λz of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 test formulation under fasted and fed (after intake of a HFHC meal) conditions in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect): AUC(0-12) of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 test formulation under fasted and fed (after intake of a HFHC meal) conditions in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect): AUC(0-24) of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 test formulation under fasted and fed (after intake of a HFHC meal) conditions in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect): AUClast of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 test formulation under fasted and fed (after intake of a HFHC meal) conditions in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect): AUCinf of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 test formulation under fasted and fed (after intake of a HFHC meal) conditions in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect): CL/F of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 test formulation under fasted and fed (after intake of a HFHC meal) conditions in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect): Vz/F of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 test formulation under fasted and fed (after intake of a HFHC meal) conditions in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect) :Frel AUC of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 test formulation under fasted and fed (after intake of a HFHC meal) conditions in healthy participants. | Day 1 to Day 3 |
| Part 3 (Food effect): Frel Cmax of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 test formulation under fasted and fed (after intake of a HFHC meal) conditions in healthy participants. | Day 1 to Day 3 |
| Part 4 (COPD): Maximum observed plasma (peak) drug concentration (Cmax) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Concentration at the end of the dosing interval (Ctrough) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Temporal change parameter (TCP) assessed in urine | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 and Day 8 |
| Part 4 (COPD): Time to reach peak or maximum observed concentration or response following drug administration (tmax) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Terminal rate constant, estimated by log linear least squares regression of the terminal part of the concentration time curve (λz) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve ( t½λz) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Partial area under the plasma concentration time curve from time 0 to time 12 (AUC(0-12)) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Partial area under the plasma concentration time curve from time 0 to time 24 (AUC(0-24)) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Area under plasma concentration time curve from zero to infinity (AUCinf) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Area under plasma concentration time curve in the dosing interval t (AUCt) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Apparent total body clearance of drug from plasma after extravascular administration (CL/F) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase) (Vz/F) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Ratio of the area under the curve (Rac AUC) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Part 4 (COPD): Accumulation ratio based on Cmax (Rac Cmax) | Characterizing the pharmacokinetic profile of AZD6793 following oral repeated administration up to 28 days (at least 26 days) in COPD participants | Day 1 to Day 28 |
| Wythenshawe |
| M23 9QZ |
| United Kingdom |