NCT06388616

Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone

A Phase I, Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group.

Detailed description

This is an open-label, non-randomised, multicentre, parallel-group, single-dose study to examine the PK, safety, and tolerability of balcinrenone 50 mg administered orally to male and female participants with mild or moderate hepatic impairment compared with control participants with normal hepatic function. Eight participants with mild impairment and 8 participants with moderate impairment per CP classification and 8 to 12 participants with normal hepatic function matched on a group level regarding age, BMI, and sex to the impaired groups are planned for study intervention. All participants will receive a single dose of balcinrenone 50 mg on Day 1 following an overnight fast. Study intervention will be administered orally with approximately 240 mL of water. Child-Pugh scoring will be used to determine the level of hepatic impairment. Participants will be enrolled into the following groups based on their CP classification score as determined at screening: * Group 1: Participants with mild hepatic impairment (CP Class A, score of 5 or 6). * Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). * Group 3: Participants with normal hepatic function matched on a group level regarding age, BMI, and sex to the impaired groups.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Balcinrenone	50 mg, Immediate release capsule to be taken orally.

Timeline

• Start date: 2024-05-02
• Primary completion: 2024-09-05
• Completion: 2024-09-05
• First posted: 2024-04-29
• Last updated: 2024-11-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study