CompletedNCT05961397Updated Aug 14, 2023

Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment

A Phase 1 interventional study of baxdrostat in Hypertension, sponsored by AstraZeneca. Completed at 5 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Apr 2022, 4 years 6 months ago, and no results have been posted to the registry.
Registered 1 year 10 months after the study started (first participant enrolled Aug 2021, registered Jul 2023).

Phase: Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Non-randomized
Ages: 18 Years to 80 Years
Sex: All

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

Browse trials for

Hypertension 6,834

Keywords

hepatic impairment
PK
baxdrostat

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 20 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

Inclusion Criteria:

Is between the ages of 18 and 80 years, inclusive, and in stable health condition. (For hepatically impaired subjects, their hepatic function category must be stable for a minimum of 3 months prior to screening.)
Is a non-nicotine user or smokes =\<10 cigarettes/day;
Has a BMI between 18 and 42 kg/m2, inclusive;
Is able to understand and willing to comply with study procedures and restrictions and provide written informed consent;
if a male subject with a female partner of childbearing potential must agree to use 2 medically accepted, highly effective methods of birth control for 90 days.
if male, must agree to abstain from sperm donation for 90 days; and
if female with a male partner, must be surgically sterile, postmenopausal, or agree to use 2 medically accepted, highly effective methods of birth control from Day -14 until 60 days after study drug dosing

Main Exclusion Criteria:

Personal or family history of long QT syndrome, torsades de pointes, or other complex ventricular arrhythmias, or family history of sudden death;
History of, or current, clinically significant arrhythmias;
Prolonged QTcF (>460 msec) based on the average of triplicate ECGs;
Estimated glomerular filtration rate (or creatinine clearance) \<50 mL/min/1.73 m2;
Evidence of any of the following: Encephalopathy grade 2 or worse, Seated systolic BP >160 mmHg and/or diastolic BP >100 mmHg, or systolic BP \<90 mmHg and/or diastolic BP \<50 mmHg, resting heart rate >100 beats per minute (bpm) or \<50 bpm, Oral temperature >37.6°C (>99.68°F), Respiration rate \<12 or >20 breaths per minute, symptomatic postural tachycardia or orthostatic hypotension, abnormal serum potassium >upper limit of normal range, abnormal serum sodium \<130 mEq/L, positive test for HIV antibody, hepatitis C , hepatitis B , or SARS-CoV-2 RNA
Current treatment with weight loss medication or prior weight loss surgery;
Use of a moderate or strong inhibitor of CYP3A4 within 14 days prior to the dose of study drug OR use of a moderate or strong inducer of CYP3A4 within 28 days prior to the dose of study drug;
Corticosteroid use (systemic or extensive topical use) within 3 months prior to study drug dosing
Pregnant, breastfeeding, or planning to become pregnant during the study

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
Normal hepatic function group
Subjects with normal hepatic function
Drug: baxdrostat
Experimental
Moderate hepatic impairment group
Subjects with a Child-Pugh score of 7 to 9 (Category B) at screening
Drug: baxdrostat

Interventions

Drugbaxdrostat
single oral dose of baxdrostat 10 mg
Also known as: CIN-107

What researchers measure

Primary outcomes

Incidence of treatment emergent adverse events following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function.
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.
Time frame: up to 72 hours post-dose
Area under the curve (AUC) for baxdrostat and the CIN-107-M metabolite following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function
Measurement of plasma concentrations of baxdrostat and its major metabolite CIN-107-M. AUC \[0 to 24 hours, 0 to last quantifiable concentration, and 0 to infinity of baxdrostat\] will be determined for baxdrostat and the CIN-107M metabolite.
Time frame: up to 72 hours post-dose
Maximum Plasma Concentration [Cmax] of baxdrostat and the CIN-107-M metabolite following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function.
Cmax will be determined for baxdrostat and the CIN-107M metabolite
Time frame: up to 72 hours post-dose
Time to Maximum Plasma Concentration [Tmax] of baxdrostat and the CIN-107-M metabolite following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function.
Tmax will be determined for baxdrostat and the CIN-107M metabolite
Time frame: up to 72 hours post-dose
Terminal elimination half-life of baxdrostat and the CIN-107-M metabolite following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function.
Terminal elimination half-life will be determined for baxdrostat and the CIN-107M metabolite
Time frame: up to 72 hours post-dose

Study locations

5 sites

Inland Empire Clinical Trials
Rialto, California 92377, United States
Advanced Pharma CR
Miami, Florida 33147, United States
Orlando Clinical Research Center
Orlando, Florida 32809, United States
Alliance for Multispecialty Research
Knoxville, Tennessee 37920, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas 78215, United States

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Supporting information: Study protocol, Statistical analysis plan

Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Data sharing details ↗ · vivli.org

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2021 to primary completion in Apr 2022, 8 months.

Of 111 industry-sponsored phase 1 interventional studies under Hypertension, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 15. This study's 8 months is above that.

Counting every sponsor, half of 158 studies reached it within 9 months; a quarter within 2 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 3, 2023
First posted: Jul 27, 2023
StartActual: Aug 10, 2021
Primary completionActual: Apr 15, 2022
CompletionActual: Apr 15, 2022
Last update: Aug 14, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05961397
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Jul 27, 2023
Start date: Aug 10, 2021
Primary completion: Apr 15, 2022
Completion: Apr 15, 2022
Last update: Aug 14, 2023

Study contacts

Kimberly Cruz, MD

principal investigator · Advanced Pharma CR

William B Smith,, MD

principal investigator · Alliance for Multispecialty Research

Zeid Kayali, MD

principal investigator · Inland Empire Clinical Trials

Thomas Marbury, MD

principal investigator · Orlando Clinical Research Center

Eric Lawitz, MD

principal investigator · American Research Corporation at the Texas Liver Institute

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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