A Phase I PK Study of Balcinrenone/Dapagliflozin in Healthy Chinese Participants

Sponsor
AstraZeneca
Study ID
NCT06651021
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • balcinrenone/dapagliflozin — DRUG
    Each participant will receive a single dose of balcinrenone/dapagliflozin 40 mg/10 mg capsule on Day 1 under fasted condition. Each participant will be involved in the study for up to 35 days.

Study Details

This study is intended to evaluate the PK, safety, and tolerability of balcinrenone/dapagliflozin given as a single dose capsule to healthy Chinese participants.

Key Dates

Start date
Oct 21, 2024
Status verified
Jan 2025
Primary completion
Oct 28, 2024
Completion
Oct 28, 2024

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: balcinrenone/dapagliflozin
    To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants

Primary Outcome Measure

AUCinf of AUCinf of balcinrenone/dapagliflozin [ Time Frame: Day 1 to post dose 48 hours ]

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