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NCT05961397 · ClinicalTrials.gov registry record · Phase 1
Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment
A Phase 1 study of Hypertension, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 5
- Study locations
NCT05961397: Completed Phase 1 study of Hypertension, sponsored by AstraZeneca.
NCT05961397 is a Phase 1 study of Hypertension that has completed, run by AstraZeneca. The registered enrollment target is 20 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05961397, a Phase 1 study of Hypertension, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 5
- Study locations
Study Summary
The goal of this Phase 1, open-label, single-dose, parallel-group study is to evaluate the pharmacokinetics (PK) of a single 10-mg oral dose of baxdrostat in subjects with varying degrees of hepatic function. The main objectives are to: * To assess the safety and tolerability of baxdrostat following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function; and * To characterize the PK of baxdrostat following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function. Participants were administered a single 10-mg oral dose of baxdrostat in the fasted state the morning of Day 1. Plasma samples were drawn at various timepoints. Safety assessments included adverse events, vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory evaluations, and physical examinations. Twenty subjects in 2 groups based on the Child-Pugh classification in the protocol at screening: up to 10 subjects in the normal hepatic function group and up to 10 subjects in the moderate hepatic impairment group. Twenty subjects entered and completed the study.
Primary Outcome
The safety and tolerability of baxdrostat was assessed throughout the study based on incidence of treatment emergent adverse events (AEs), following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function.
Conditions Studied
Interventions
- DRUG baxdrostat
Study Locations (5)
Florida
- Advanced Pharma CR - Miami
- Orlando Clinical Research Center - Orlando
California
- Inland Empire Clinical Trials - Rialto
Tennessee
- Alliance for Multispecialty Research - Knoxville
Texas
- American Research Corporation at the Texas Liver Institute - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-08-10 |
| Est. Completion | 2022-04-15 |
| Phase | Phase 1 |
What the finished NCT05961397 record still lists
NCT05961397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which baxdrostat is the first listed.
NCT05961397 lists 5 locations in 4 states (Florida, California, Tennessee).
Frequently Asked Questions
What is clinical trial NCT05961397 about?
NCT05961397 is a clinical study titled "Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment". The goal of this Phase 1, open-label, single-dose, parallel-group study is to evaluate the pharmacokinetics (PK) of a single 10-mg oral dose of baxdrostat in subjects with varying degrees of hepatic function. The main objectives are to: * To assess the safety and tolerability of baxdrostat followin...
What is the current status of trial NCT05961397?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-08-10. Estimated completion is 2022-04-15.
What conditions does trial NCT05961397 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT05961397?
The interventions under investigation include: baxdrostat (DRUG).
Who is sponsoring clinical trial NCT05961397?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05961397 being conducted?
This trial has 5 study locations across California, Florida, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05961397's enrollment target sits among peer trials
20 438th of 470 higher than 24 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension 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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