Healthy ParticipantsPhase 1NCT06368440
A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants
A Phase 1 study testing AZD6793 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD6793
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 23 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- For Japanese participants only:
- Participant was born in Japan
- Participant has 2 Japanese biological parents and 4 Japanese grandparents as confirmed by the interview.
- Participant did not live outside of Japan for more than 10 years at the time of the Screening Visit.
- For Chinese participants only:
- Participant was born in China (including Hong Kong, Macau, and Taiwan)
- Participant has 2 Chinese biological parents and 4 Chinese grandparents as confirmed by the interview.
- Participant did not live outside of greater China for more than 10 years at the time of the Screening Visit.
- 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:
- Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy (but not tubal ligation).
Main Exclusion Criteria:
- 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.
- Diagnosis or history of immunodeficiency or increased susceptibility to severe infection, or a clinically significant infection within 4 weeks of the Screening Visit.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis B core antibody, or human immunodeficiency virus.
- 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.
- 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.
- 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.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the Investigator.
- Positive screen for drugs of abuse, or alcohol or cotinine at the Screening Visit or admission to the Clinical Unit (Day -1).
- 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).
- Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of an Oral Suspension of AZD6793 Following Single and Multiple Doses in Japanese and Chinese Healthy Participants
The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants.
Read the detailed description
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:
- A Screening Period of maximum 28 days (Day -29 to Day -2).
- A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 until at least 72 hours after study intervention administration.
- A Follow-up Visit within 6 ± 1 days after the study intervention administration.
Part 2 of the study will comprise:
- A Screening Period of maximum 28 days (Day -29 to Day -2).
- A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 (the day before first study intervention administration [Day 1]) until Day 10.
- A Follow-up Visit within 6 ± 1 days after the last study intervention administration.
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.
- Conditions
- Healthy Participants
- Being tested
- AZD6793, Placebo
- Keywords
- Chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6793Drug
Participants will receive AZD6793 single dose as oral suspension.
AZD6793Drug
Participants will receive AZD6793 multiple doses daily as oral suspension.
PlaceboDrug
Participants will receive matching doses of placebo as oral suspension.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AZD6793; Drug: Placebo |
| 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. Receives: Drug: AZD6793; Drug: Placebo |
| 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. Receives: Drug: AZD6793; Drug: Placebo |
| 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. Receives: Drug: AZD6793; Drug: Placebo |
| Part 2: Cohort 2 AZD6793 | Experimental | 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. Receives: Drug: AZD6793; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From Day 1 up to Follow up visit (Day 14±1)
Secondary outcomes (33)
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.
Measured: Day 1 to Day 3
Part 1 (SAD): Time to Reach Peak Concentration (tmax)
To characterize PK of AZD6793 following oral administration of single ascending doses in healthy Japanese participants and a single dose in healthy Chinese participants.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 1, 2, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start15 May 2024
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368440
- Sponsor's protocol ID
- D7860C00003
- Status last verified
- Oct 2025
- First submitted
- 11 Apr 2024
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of an Oral Suspension of AZD6793 Following Single and Multiple Doses in Japanese and Chinese Healthy Participants
- ClinicalTrials.gov ID
- NCT06368440
- Acronym / sponsor ID
- D7860C00003
- Conditions
- Healthy Participants
- Keywords
- Chronic obstructive pulmonary disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants.
Detailed description
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:
- A Screening Period of maximum 28 days (Day -29 to Day -2).
- A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 until at least 72 hours after study intervention administration.
- A Follow-up Visit within 6 ± 1 days after the study intervention administration.
Part 2 of the study will comprise:
- A Screening Period of maximum 28 days (Day -29 to Day -2).
- A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 (the day before first study intervention administration [Day 1]) until Day 10.
- A Follow-up Visit within 6 ± 1 days after the last study intervention administration.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1 AZD6793 | Experimental | Drug: AZD6793, Drug: Placebo6 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 | Drug: AZD6793, Drug: Placebo6 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 | Drug: AZD6793, Drug: Placebo6 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 | Drug: AZD6793, Drug: Placebo6 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 | Drug: AZD6793, Drug: Placebo6 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD6793Participants will receive AZD6793 single dose as oral suspension. | Drug | Part 1: Cohort 1 AZD6793, Part 1: Cohort 2 AZD6793, Part 1: Cohort 3 AZD6793 |
| AZD6793Participants will receive AZD6793 multiple doses daily as oral suspension. | Drug | Part 2: Cohort 1 AZD6793, Part 2: Cohort 2 AZD6793 |
| PlaceboParticipants will receive matching doses of placebo as oral suspension. | Drug | Part 1: Cohort 1 AZD6793, Part 1: Cohort 2 AZD6793, Part 1: Cohort 3 AZD6793, Part 2: Cohort 1 AZD6793, Part 2: Cohort 2 AZD6793 |
Primary outcome
Part 1 (SAD): Number of Participants with Adverse Events
Time frame: From Day 1 up to Follow up visit (Day 7±1)
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.
Part 2 (MAD): Number of Participants with Adverse Events
Time frame: From Day 1 up to Follow up visit (Day 14±1)
To assess the safety and tolerability of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
33 secondary outcomes
Part 1 (SAD) : Maximum Observed Plasma Drug Concentration
Time frame: Day 1 to Day 3
Part 1 (SAD): Time to Reach Peak Concentration (tmax)
Time frame: 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)
Time frame: Day 1 to Day 3
Part 1 (SAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz)
Time frame: 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])
Time frame: 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])
Time frame: Day 1 to Day 3
Part 1 (SAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast)
Time frame: Day 1 to Day 3
Part 1 (SAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf)
Time frame: Day 1 to Day 3
Part 1 (SAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F)
Time frame: Day 1 to Day 3
Part 1 (SAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F)
Time frame: Day 1 to Day 3
Part 1 (SAD): Dose Normalized AUClast
Time frame: Day 1 to Day 3
Part 1 (SAD): Dose Normalized AUCinf
Time frame: Day 1 to Day 3
Part 1 (SAD): Dose Normalized Cmax
Time frame: Day 1 to Day 3
Part 2 (MAD): Maximum Observed Plasma Drug Concentration (Cmax)
Time frame: Day 1 to Day 10
Part 2 (MAD) : Concentration at the End of The Dosing Interval (Ctrough)
Time frame: Day 1 to Day 10
Part 2 (MAD): Temporal Change Parameter (TCP)
Time frame: Day 1 to Day 10
Part 2 (MAD): Time to Reach Peak Concentration (tmax)
Time frame: 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)
Time frame: Day 1 to Day 10
Part 2 (MAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz)
Time frame: 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])
Time frame: Day 1 to Day 10
Part 2 (MAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast)
Time frame: Day 1 to Day 10
Part 2 (MAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf)
Time frame: Day 1 to Day 10
Part 2 (MAD): Area Under Plasma Concentration-Time Curve in The Dosing Interval Tau (AUCtau)
Time frame: Day 1 to Day 10
Part 2 (MAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F)
Time frame: Day 1 to Day 10
Part 2 (MAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F)
Time frame: Day 1 to Day 10
Part 2 (MAD): Dose Normalized AUClast
Time frame: Day 1 to Day 10
Part 2 (MAD): Dose Normalized AUCtau
Time frame: Day 1 to Day 10
Part 2 (MAD): Dose Normalized Cmax
Time frame: Day 1 to Day 10
Part 2 (MAD): Ratio of the Area Under the Curve (Rac AUC)
Time frame: Day 1 to Day 10
Part 2 (MAD): Accumulation Ratio Based on Cmax (Rac Cmax)
Time frame: Day 1 to Day 10
Part 2 (MAD): Amount of Unchanged Drug Excreted into Urine from Time t1 to Time t2 (Ae[t1-t2])
Time frame: Days 1, 2, and 8
Part 2 (MAD): Cumulative Amount of Unchanged Drug Excreted into Urine (Aeinf)
Time frame: Days 1, 2, and 8
Part 2 (MAD): Renal Clearance (CLR)
Time frame: Days 1, 2, and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- D7860C00003\_CSR Synopsis\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6793 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 (SAD): Number of Participants with Adverse Events (time frame: From Day 1 up to Follow up visit (Day 7±1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.