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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06388616
The ClinicalTrials.gov registry entry for NCT06388616 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (17% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.