Research Site
Glendale, California, 91206, United States
NCT Number: NCT06368440
The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Glendale, California, 91206, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Main Inclusion Criteria:
Main Exclusion Criteria:
Participants will receive AZD6793 single dose as oral suspension.
Participants will receive matching doses of placebo as oral suspension.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
Time frame: Day 1 to Day 10
To characterize PK of AZD6793 following oral administration of multiple doses in healthy Japanese and Chinese participants.
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.
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.
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.
AstraZeneca
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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