NCT06651021

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

A Phase I, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability Following Administration of a Single Dose of Balcinrenone/Dapagliflozin in Healthy Chinese Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is a Phase I, open-label, single-arm, single dose PK study in healthy Chinese participants to be conducted at a single study centre in mainland China. In this study, approximately 10 participants (both females and males) will be assigned to the IMP. Each participant will receive a single dose of a capsule with balcinrenone/dapagliflozin 40 mg/10 mg on Day 1 under fasted condition. The study will comprise of the following: * A screening period * A treatment period * A follow-up visit At the discretion of the investigator, the participant may remain in the study center until the completion of the follow-up visit

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	balcinrenone/dapagliflozin	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.

Timeline

• Start date: 2024-10-21
• Primary completion: 2024-10-28
• Completion: 2024-10-28
• First posted: 2024-10-21
• Last updated: 2025-01-15

Locations

1 site across 1 country: China