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The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants.
This study will be conducted to assess the safety, tolerability, and PK of oral AZD6793 suspension following single (Part 1) and multiple (Part 2) administrations in healthy Japanese and Chinese participants performed at a single Clinical Unit.
Part 1 of the study will comprise:
Part 2 of the study will comprise:
Participants will be randomized to receive AZD6793 and placebo in both Part 1 and Part 2.
Participants who enrolled in Part 1 will be excluded from participation in Part 2 of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Cohort 1 AZD6793 | Experimental | 6 Healthy Japanese participants will receive single dose of AZD6793 dose 1 and 2 healthy Japanese participants will receive matching placebo to AZD6793 as oral suspension on Day 1. |
|
| Part 1: Cohort 2 AZD6793 | Experimental | 6 Healthy Japanese participants will receive single dose of AZD6793 dose 2 and 2 healthy Japanese participants will receive matching placebo to AZD6793 as oral suspension on Day 1. |
|
| Part 1: Cohort 3 AZD6793 | Experimental | 6 Healthy Chinese participants will receive single dose of AZD6793 dose 1 and 2 healthy Chinese participants will receive matching placebo to AZD6793 as oral suspension on Day 1. |
|
| Part 2: Cohort 1 AZD6793 | Experimental | 6 Japanese participants will receive single dose of AZD6793 and 2 participants will receive matching placebo on Day 1. After a washout of at least 48 hours, participants will receive AZD6793 or placebo once daily from Day 3 to Day 8. |
|
| Part 2: Cohort 2 AZD6793 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6793 | Drug | Participants will receive AZD6793 single dose as oral suspension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (SAD): Number of Participants with Adverse Events | To assess the safety and tolerability of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | From Day 1 up to Follow up visit (Day 7±1) |
| Part 2 (MAD): Number of Participants with Adverse Events | To assess the safety and tolerability of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | From Day 1 up to Follow up visit (Day 14±1) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (SAD) : Maximum Observed Plasma Drug Concentration | To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | Day 1 to Day 3 |
| Part 1 (SAD): Time to Reach Peak Concentration (tmax) |
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Main Inclusion Criteria:
For Japanese participants only:
For Chinese participants only:
All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception,
Have a body mass index between 18 and 30 kilograms per meter square (kg/m2) inclusive and weigh at least 45 kilograms (kg), at the Screening Visit.
Females of non-childbearing potential must be confirmed at the screening Visit by fulfilling one of the following criteria:
Main Exclusion Criteria:
1. History of any clinically important disease or disorder or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
3. Diagnosis or history of immunodeficiency or increased susceptibility to severe infection, or a clinically significant infection within 4 weeks of the Screening Visit.
4. Any positive result on screening for serum hepatitis B surface antigen, hepatitis B core antibody, or human immunodeficiency virus.
5. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD6793.
6. Plasma donation within one month of the Screening Visit or any blood donation/blood loss greater than (>) 500 milliliter (mL) during the 3 months prior to the Screening Visit.
7. Participants who have previously received AZD6793. 8. Positive or indeterminate QuantiFERON® TB test at Screening Visit. 9. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months prior to the Screening Visit.
10. Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the Investigator.
11. Positive screen for drugs of abuse, or alcohol or cotinine at the Screening Visit or admission to the Clinical Unit (Day -1).
12. Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) defined as the regular consumption of more than 500 mg of caffeine per day (eg, > 5 cups of coffee [one cup ~100 mg caffeine]; one cup of tea ~30 mg caffeine).
13. Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | 91206 | United States |
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| Label | URL |
|---|---|
| D7860C00003\_CSR Synopsis\_Redacted | 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 Vivli.org. All requests 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 approved.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure researchenvironmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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6 Chinese participants will receive single dose of AZD6793 and 2 participants will receive matching placebo on Day 1. After a washout of at least 48 hours, participants will receive AZD6793 or placebo once daily from Day 3 to Day 8.
|
| AZD6793 | Drug | Participants will receive AZD6793 multiple doses daily as oral suspension. |
|
| Placebo | Drug | Participants will receive matching doses of placebo as oral suspension. |
|
To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese 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) | To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | Day 1 to Day 3 |
| Part 1 (SAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz) | To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | Day 1 to Day 3 |
| Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 12 (AUC[0-12]) | To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | Day 1 to Day 3 |
| Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]) | To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | Day 1 to Day 3 |
| Part 1 (SAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) | To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | Day 1 to Day 3 |
| Part 1 (SAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) | To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | Day 1 to Day 3 |
| Part 1 (SAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) | To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | Day 1 to Day 3 |
| Part 1 (SAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F) | To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | Day 1 to Day 3 |
| Part 1 (SAD): Dose Normalized AUClast | To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | Day 1 to Day 3 |
| Part 1 (SAD): Dose Normalized AUCinf | To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | Day 1 to Day 3 |
| Part 1 (SAD): Dose Normalized Cmax | To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants. | Day 1 to Day 3 |
| Part 2 (MAD): Maximum Observed Plasma Drug Concentration (Cmax) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD) : Concentration at the End of The Dosing Interval (Ctrough) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Temporal Change Parameter (TCP) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Time to Reach Peak Concentration (tmax) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese 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) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Area Under Plasma Concentration-Time Curve in The Dosing Interval Tau (AUCtau) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Dose Normalized AUClast | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Dose Normalized AUCtau | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Dose Normalized Cmax | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Ratio of the Area Under the Curve (Rac AUC) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Accumulation Ratio Based on Cmax (Rac Cmax) | To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants. | Day 1 to Day 10 |
| Part 2 (MAD): Amount of Unchanged Drug Excreted into Urine from Time t1 to Time t2 (Ae[t1-t2]) | To characterize PK of AZD6793 in urine following oral administration of multiple doses in healthy Japanese and Chinese participants. | Days 1, 2, and 8 |
| Part 2 (MAD): Cumulative Amount of Unchanged Drug Excreted into Urine (Aeinf) | To characterize PK of AZD6793 in urine following oral administration of multiple doses in healthy Japanese and Chinese participants. | Days 1, 2, and 8 |
| Part 2 (MAD): Renal Clearance (CLR) | To characterize PK of AZD6793 in urine following oral administration of multiple doses in healthy Japanese and Chinese participants. | Days 1, 2, and 8 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |