A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368440
• Other study ID #: D7860C00003
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 15, 2024
• Est. completion date: October 4, 2024

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 4, 2024
• Est. primary completion date: October 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Main Inclusion Criteria:

1. For Japanese participants only:

1. Participant was born in Japan

2. Participant has 2 Japanese biological parents and 4 Japanese grandparents as confirmed by the interview.

3. Participant did not live outside of Japan for more than 10 years at the time of the Screening Visit.

2. For Chinese participants only:

1. Participant was born in China (including Hong Kong, Macau, and Taiwan)

2. Participant has 2 Chinese biological parents and 4 Chinese grandparents as confirmed by the interview.

3. Participant did not live outside of greater China for more than 10 years at the time of the Screening Visit.

3. All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.

4. Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception,

5. 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.

6. Females of non-childbearing potential must be confirmed at the screening Visit by

fulfilling one of the following criteria:

1. Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.

2. 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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• AZD6793
Participants will receive AZD6793 single dose as oral suspension.
• AZD6793
Participants will receive AZD6793 multiple doses daily as oral suspension.
• Placebo
Participants will receive matching doses of placebo as oral suspension.

Locations

Country	Name	City	State
United States	Research Site	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Secondary	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
Secondary	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.	Day 1 to Day 3
Secondary	Part 1 (SAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (?z)	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
Secondary	Part 1 (SAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2?z)	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Part 2 (MAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (?z)	To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.	Day 1 to Day 10
Secondary	Part 2 (MAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2?z)	To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.	Day 1 to Day 10
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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