- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06368440
A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
-
-
California
-
Glendale, California, United States, 91206
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: Cohort 1 AZD6793
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.
|
Participants will receive AZD6793 single dose as oral suspension.
Participants will receive AZD6793 multiple doses daily as oral suspension.
Participants will receive matching doses of placebo as oral suspension.
|
Experimental: Part 1: Cohort 2 AZD6793
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.
|
Participants will receive AZD6793 single dose as oral suspension.
Participants will receive AZD6793 multiple doses daily as oral suspension.
Participants will receive matching doses of placebo as oral suspension.
|
Experimental: Part 1: Cohort 3 AZD6793
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.
|
Participants will receive AZD6793 single dose as oral suspension.
Participants will receive AZD6793 multiple doses daily as oral suspension.
Participants will receive matching doses of placebo as oral suspension.
|
Experimental: Part 2: Cohort 1 AZD6793
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.
|
Participants will receive AZD6793 single dose as oral suspension.
Participants will receive AZD6793 multiple doses daily as oral suspension.
Participants will receive matching doses of placebo as oral suspension.
|
Experimental: Part 2: Cohort 2 AZD6793
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.
|
Participants will receive AZD6793 single dose as oral suspension.
Participants will receive AZD6793 multiple doses daily as oral suspension.
Participants will receive matching doses of placebo as oral suspension.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From Day 1 up to Follow up visit (Day 7±1)
|
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.
|
From Day 1 up to Follow up visit (Day 14±1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1 (SAD) : Maximum Observed Plasma Drug Concentration
Time Frame: Day 1 to Day 3
|
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)
Time Frame: Day 1 to Day 3
|
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)
Time Frame: Day 1 to Day 3
|
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)
Time Frame: Day 1 to Day 3
|
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])
Time Frame: Day 1 to Day 3
|
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])
Time Frame: Day 1 to Day 3
|
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)
Time Frame: Day 1 to Day 3
|
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)
Time Frame: Day 1 to Day 3
|
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)
Time Frame: Day 1 to Day 3
|
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)
Time Frame: Day 1 to Day 3
|
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
Time Frame: Day 1 to Day 3
|
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
Time Frame: Day 1 to Day 3
|
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
Time Frame: Day 1 to Day 3
|
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)
Time Frame: Day 1 to Day 10
|
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)
Time Frame: Day 1 to Day 10
|
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)
Time Frame: Day 1 to Day 10
|
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)
Time Frame: Day 1 to Day 10
|
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)
Time Frame: Day 1 to Day 10
|
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)
Time Frame: Day 1 to Day 10
|
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])
Time Frame: Day 1 to Day 10
|
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)
Time Frame: Day 1 to Day 10
|
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)
Time Frame: Day 1 to Day 10
|
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)
Time Frame: Day 1 to Day 10
|
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)
Time Frame: Day 1 to Day 10
|
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)
Time Frame: Day 1 to Day 10
|
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
Time Frame: Day 1 to Day 10
|
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
Time Frame: Day 1 to Day 10
|
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
Time Frame: Day 1 to Day 10
|
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)
Time Frame: Day 1 to Day 10
|
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)
Time Frame: Day 1 to Day 10
|
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])
Time Frame: Days 1, 2, and 8
|
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)
Time Frame: Days 1, 2, and 8
|
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)
Time Frame: Days 1, 2, and 8
|
To characterize PK of AZD6793 in urine following oral administration of multiple doses in healthy Japanese and Chinese participants.
|
Days 1, 2, and 8
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- D7860C00003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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