A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy and Chronic Obstructive Pulmonary Disease Participants, to Assess the Relative Oral Bioavailability Between Two Formulations, and the Food Effect on the PK of AZD6793 Compared to Fasting State.

NCT05662033 | Completed Phase 1

• 2 other identifiers: D7860C000012022-002951-21
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Inflammatory Diseases

Keywords

IRAK4 kinase inhibitor; AZD6793

Outcome Measures

Primary Outcomes (23)

• 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)

  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)

Secondary Outcomes (72)

• Part 1 (SAD): Maximum observed plasma (peak) drug concentration (Cmax)

  Day 1 to Day 3

• Part 1 (SAD): Time to reach peak or maximum observed concentration or response following drug administration (tmax)

  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)

  Day 1 to Day 3

• Part 1 (SAD): Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve ( t½λz)

  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))

  Day 1 to Day 3

Study Arms (13)

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

Drug: AZD6793; Drug: Placebo

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

Drug: AZD6793; Drug: Placebo

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

Drug: AZD6793; Drug: Placebo

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

Drug: AZD6793; Drug: Placebo

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

Drug: AZD6793; Drug: Placebo

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

Drug: AZD6793; Drug: Placebo

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

Drug: AZD6793; Drug: Placebo

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

Drug: AZD6793; Drug: Placebo

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

Drug: AZD6793; Drug: Placebo

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.

Drug: AZD6793

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.

Drug: AZD6793

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.

Drug: AZD6793

Part 4 (COPD): Cohort 1

EXPERIMENTAL

10 participants with COPD will receive AZD6793 once daily and 5 participants with COPD will receive placebo

Drug: AZD6793; Drug: Placebo

Interventions

AZD6793 DRUG

AZD6793 will be administered orally

Part 1 (SAD): Cohort 1; Part 1 (SAD): Cohort 2; Part 1 (SAD): Cohort 3; Part 1 (SAD): Cohort 4; Part 1 (SAD): Cohort 5; Part 2 (MAD) : Cohort 4; Part 2 (MAD): Cohort 1; Part 2 (MAD): Cohort 2; Part 2 (MAD): Cohort 3; Part 3: Treatment sequence 1; Part 3: Treatment sequence 2; Part 3: Treatment sequence 3; Part 4 (COPD): Cohort 1

Placebo DRUG

Placebo will be administered orally

Part 1 (SAD): Cohort 1; Part 1 (SAD): Cohort 2; Part 1 (SAD): Cohort 3; Part 1 (SAD): Cohort 4; Part 1 (SAD): Cohort 5; Part 2 (MAD) : Cohort 4; Part 2 (MAD): Cohort 1; Part 2 (MAD): Cohort 2; Part 2 (MAD): Cohort 3; Part 4 (COPD): Cohort 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parts 1,2 and 3:
• Healthy male or female participants aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture
• Females must have a negative pregnancy test must not be lactating and must be either (a) non-childbearing potential, confirmed by post-menopausal defined as amenorrhea for at least 12 months; documentation of irreversible surgical sterilisation or (b) childbearing potential, i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile (Must agree to use, with their partner, an approved method of highly effective contraception).
• Male participants and their female partners of childbearing potential must be willing to use highly effective contraception measures and male participants must refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the last dose of IMP.
• Have a BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg, at the Screening Visit.
• 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 :
• Non-childbearing potential confirmed at screening
• If considered of childbearing potential, must agree to use with their partner an approved method of highly effective contraception.
• 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.

You may not qualify if:

• Parts 1,2 and 3:
• History or presence of gastrointestinal, hepatic, renal, pancreatic disease or acute disease in these organs.
• History of chronic haematologic disease.
• Diagnosis or history of immunodeficiency or increased susceptibility to severe infection, or a clinically significant infection
• Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
• Positive or indeterminate QuantiFERON® Tuberculosis (TB) test at screening.
• Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results
• Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg), hepatitis C antibody and Human immunodeficiency virus (HIV).
• Any clinically important abnormalities in rhythm, conduction or morphology of the resting Electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
• Known or suspected history of alcohol and drug abuse in the last year.
• Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the previous 3 months.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD6793.
• Excessive intake of caffeine containing drinks or food
• Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
• Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

Research Site

Wythenshawe, M23 9QZ, United Kingdom

Location

Related Links

• Redacted CSR Synopsis

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 22, 2022
• Study Start: December 5, 2022
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.
• Access Criteria: 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.

Locations

GB (2)