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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 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.

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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.

Conditions Studied

Hypertension

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

FieldValue
Enrollment Target 20 participants
Start Date 2021-08-10
Est. Completion 2022-04-15
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05961397

The ClinicalTrials.gov registry entry for NCT05961397 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 4 distinct geographic areas - top geographies include 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.

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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.