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NCT06388616 · ClinicalTrials.gov registry record · Phase 1
Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone
A Phase 1 study of Hepatic Impairment, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT06388616: Completed Phase 1 study of Hepatic Impairment, sponsored by AstraZeneca.
NCT06388616 is a Phase 1 study of Hepatic Impairment that has completed, run by AstraZeneca. The registered enrollment target is 30 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (17% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06388616, a Phase 1 study of Hepatic Impairment, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
To compare the PK of a single oral dose of balcinrenone in participants with mild and moderate hepatic impairment to those with normal hepatic function
Conditions Studied
Interventions
- DRUG Balcinrenone
Study Locations (3)
Florida
- Research Site - Hialeah
- Research Site - Orlando
Texas
- Research Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-05-02 |
| Est. Completion | 2024-09-05 |
| Phase | Phase 1 |
What the finished NCT06388616 record still lists
NCT06388616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Balcinrenone is the first listed.
NCT06388616 reports a single indexed study location in Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT06388616 about?
NCT06388616 is a clinical study titled "Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone". 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.
What is the current status of trial NCT06388616?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-05-02. Estimated completion is 2024-09-05.
What conditions does trial NCT06388616 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT06388616?
The interventions under investigation include: Balcinrenone (DRUG).
Who is sponsoring clinical trial NCT06388616?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06388616 being conducted?
This trial has 3 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06388616's enrollment target sits among peer trials
30 21st of 48 higher than 24 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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